Prestwick3_000017

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

33 API Suppliers, 20 USDMF, 13 CEP/COS, 4 JDMF, 2 EU WC, 9 KDMF, 12 NDC API, 14 Listed Suppliers

DEVELOPMENTS

34 Drug(s) in Development

34 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

INTERMEDIATES

5 Suppliers

5 Suppliers

DOSSIERs // Finished Dosage Formulations

316 Dossiers, 119 FDA Orange Book, 122 Europe, 26 Canada, 5 Australia, 14 South Africa, 30 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 10MG;100MG, TABLET;ORAL - 25MG;100MG, TABLET;ORAL - 25MG;250MG, TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 12.5MG;200MG;50MG, TABLET;ORAL - 18.75MG;200MG;75MG, TABLET;ORAL - 25MG;200MG;100MG, TABLET;ORAL - 31.25MG;200MG;125MG, TABLET;ORAL - 37.5MG;200MG;150MG, TABLET;ORAL - 50MG;200MG;200MG

TABLET;ORAL - 10MG;100MG
TABLET;ORAL - 25MG;100MG
TABLET;ORAL - 25MG;250MG
TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 12.5MG;200MG;50MG
TABLET;ORAL - 18.75MG;200MG;75MG
TABLET;ORAL - 25MG;200MG;100MG
TABLET;ORAL - 31.25MG;200MG;125MG
TABLET;ORAL - 37.5MG;200MG;150MG
TABLET;ORAL - 50MG;200MG;200MG

RELATED EXCIPIENT COMPANIES

Suppliers, 33 Kerry, 29 BASF, 29 Roquette, 20 SPI Pharma, 17 Microlex e.U, 13 Gangwal Healthcare, 13 Seppic, 12 Corel Pharma Chem, 12 Sigachi Industries, 12 Gangwal Chemicals, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 Ideal Cures Pvt Ltd, 8 Actylis, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 7 Boai NKY Pharmaceuticals Ltd, 6 Lonza Capsugel, 6 DFE Pharma, 5 Kima Chemical, 5 Prachin Chemical, 5 Pharmatrans-Sanaq, 5 Ingredion Pharma Solutions, 5 Nanjing Well Pharmaceutical, 4 Vasa Pharmachem, 4 DKSH, 4 Rochem International Inc, 4 The Dow Chemical Company, 3 Jai Radhe Sales, 3 Ulanqab Kema New Material, 2 Shijiazhuang Huaxu Pharmaceutical, 2 Evonik, 2 Pfanstiehl, 2 Alcedo Pharmachem, 2 Nomisma Healthcare, 2 Seqens, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Aeon Procare, 1 ACG Worldwide, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Qualicaps, 1 NEWEDGE Overseas, 1 Chynops Pharma, 1 Nanjing Bold Chemical, 1 Minakem, 1 Finar, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

88 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 46 Disintegrants & Superdisintegrants, 43 Direct Compression, 39 Controlled & Modified Release, 31 Solubilizers, 30 Granulation, 29 Thickeners and Stabilizers, 26 Taste Masking, 22 Lubricants & Glidants, 21 Chewable & Orodispersible Aids, 21 Film Formers & Plasticizers, 19 Parenteral, 16 Co-Processed Excipients, 12 Topical, 9 API Stability Enhancers, 7 Emulsifying Agents, 6 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Soft Gelatin

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 107 Finished Drug Prices

MARKET PLACE

22 APIs, 5 DOSSIERS // FDF

PATENTS

71 US Patents

71 US Patents

ANALYTICAL SOLUTION(s)

1 BioAnalytical Methods, 1 EDQM Standards, 3 USP Standards, 4 Other Ref. Standards

DIGITAL CONTENT

6 Data Compilations & Company Tracker #PharmaFlow, 86 News

Blog

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Top drugs and pharmaceutical companies of 2019 by revenues

Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues. Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively. Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention. GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion). US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic. Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)

Impressions: 54752

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#PharmaFlow by PHARMACOMPASS

29 Apr 2020

Pharma Deals, Investments and M&As in March 2018

If the first two months of 2018 saw pharma and biotech firms receive more money than what all biotech companies raised throughout 2013, March witnessed the biggest takeover transaction of the year so far — health insurer Cigna Corporation acquired pharmacy benefit manager (PBM) Express Scripts Holding for around US$ 67 billion. Healthcare shakeout in the United States continues As part of a shakeout in healthcare that has indeed gathered momentum in the United States, primarily in response to the growing frustration over drug pricing, health insurer Cigna Corporation has agreed to buy pharmacy benefit manager (PBM) Express Scripts Holding for around US$ 67 billion. Click here to view the major deals in March 2018 (FREE Excel version available) As of 2017, Express Scripts is the largest of the remaining independent PBMs. The deal would give the two companies substantial bargaining power over drug prices in the US. Healthcare spending has been rising rapidly, accounting for an estimated 18 percent of the US economy in 2017. PBMs, such as Express Scripts, negotiate drug benefits for insurance plans and employers. The medical supply chain has become cumbersome. Insurers, PBMs, drug distributors, pharmacies, and large medical groups — all get a cut of the profits from caring for patients. Bringing these businesses under one roof could streamline costs and improve care. The deal could help Cigna compete with players like CVS Health Corp and UnitedHealth Group Inc. The former recently acquired Aetna Inc. for around US$ 69 billion, linking its pharmacies and drug-benefit plans with the insurer’s coverage. There are lots happening in the PBM space. In March, Andrew Witty, former CEO of GlaxoSmithKline who retired from the British drug major a year back, announced he was taking a leadership role in managing drug benefits in one of the largest, fastest growing outfits in the US. Click here to view the major deals in March 2018 (FREE Excel version available) Witty has been named the new CEO of UnitedHealth’s Optum division, a PBM group and healthcare analytics company. Optum has 140,000 staffers around the world. It earns roughly half of UnitedHealth’s revenue (which was US$ 201 billion in 2017) from its three key subsidiaries — OptumHealth and OptumInsight as well as OptumRx. Merck continues its cancer drug deal making Japan’s Eisai Co and US-based Merck & Co announced a potential multibillion-dollar deal to develop and sell Eisai’s cancer drug Lenvima, which is already approved in dozens of countries as treatment for thyroid cancer and advanced kidney cancer (when used along with another medicine). As per the deal, the Japanese drugmaker could potentially receive up to US$ 5.76 billion if it proves a success. This includes an upfront payment of US$ 750 million. The remaining US$ 5.01 billion will be paid by Merck for development achievements and sales milestones, a joint statement said. Merck will be entitled to half of all global Lenvima sales revenue, even for its already approved uses for thyroid cancer and advanced kidney cancer. The deal is similar to a multibillion-dollar oncology collaboration Merck struck with AstraZeneca Plc for its cancer drug Lynparza last year. Click here to view the major deals in March 2018 (FREE Excel version available) Ionis buys back into company it spun-off less than a year ago Akcea Therapeutics, a biotech company focused on rare diseases caused by lipid disorders, was founded in 2015 as a subsidiary of Ionis Pharmaceuticals. Its drug pipeline of four drug candidates were developed using Ionis’ technology and its most advanced drug was volanesorsen, a drug developed to treat familial partial lipodystrophy, or FPL. A year ago, Akcea was spun out of its parent as it filed an initial public stock offering (IPO) to drive forward the FDA approval for its lead drug which is expected by mid-2018. Last month, Ionis announced that it has signed an exclusive, worldwide licensing deal with Akcea related to two of its other drugs - inotersen and AKCEA-TTR-LRx, formerly IONIS-TTR-LRx. The total milestone payments associated with this deal are $1.3 billion while the transaction could make Ionis eligible for up to $1.7 billion, plus profit-sharing payments. Click here to view the major deals in March 2018 (FREE Excel version available) Interim Lundbeck CEO’s billion-dollar buy Denmark-based H. Lundbeck announced it was acquiring Prexton Therapeutics for US$ 123 million. Lundbeck is also committing an additional US$ 1 billion in milestones — with more than half of that tied to sales goals. Prexton Therapeutics was formed as a spin-off from Merck in 2012. The acquisition has a mid-stage Parkinson’s drug— foliglurax — at its core. The drug is in Phase II testing for the symptomatic treatment of Parkinson’s disease and dyskinesia, including Levodopa Induced Dyskinesia (LID). First data from the ongoing clinical Phase II program is expected to be available in the first half of 2019, the company said. Click here to view the major deals in March 2018 (FREE Excel version available) Anders Götzsche, the interim CEO of Lundbeck, said the acquisition will provide Lundbeck full control of the future of foliglurax. “Foliglurax addresses high unmet needs with its potential indication in Parkinson’s fitting perfectly within Lundbeck’s core areas and this treatment option also appears to be highly interesting for patients, physicians and payers,” Götzsche said. Click here to view the major deals in March 2018 (FREE Excel version available) The Phase II trial, which began in 2017, will add foliglurax to standard care of treatment for Parkinson’s disease, which includes drugs like levodopa. The primary goal of the Phase II trial is to assess efficacy, safety and tolerability of foliglurax in reducing motor complications of levodopa therapy in patients experiencing end-of-dose wearing-off and LID. GlaxoSmithKline doubles down on OTC Over the past few months, there has been a lot of speculation around who will acquire Pfizer’s consumer health division auction has been the subject of a lot of speculation over the past few months. Last month Reckitt Benckiser pulled out of the race and British drug major GlaxoSmithKline was considered the leader in the race for the division. However, GSK too withdrew from the deal talks. While there was news that Glaxo had made a final bid valuing Pfizer’s over-the-counter (OTC) treatments at about US$ 15 billion to US$ 20 billion, GSK announced it had reached an agreement with Novartis to acquire full ownership of its consumer healthcare business. GSK will buy out Novartis’ 36.5 percent stake in a joint venture worth US$ 13 billion (£9.2 billion). Click here to view the major deals in March 2018 (FREE Excel version available) With this acquisition, GSK is in full control of a joint venture that owns successful OTC products like Sensodyne toothpaste, Panadol headache tablets and Nicotinell patches. In 2017, the business reported sales of US$ 11 billion (£7.8 billion). Japan’s Fujifilm bets on the market for cell culture media Irvine Scientific Sales Company (ISUS) and IS Japan (ISJ), two companies specializing in cell culture media were acquired last month for $800 million by Japan’s Fujifilm. In recent years, culture media has received increased interests as it contains the nutrients required for the growth and proliferation of cells essential for cell culturing in the R&D and manufacturing of biopharmaceuticals and regenerative medicine products. Most importantly, the quality of the culture medium can influence the quality and efficiency of cell culturing. Click here to view the major deals in March 2018 (FREE Excel version available) “The market for cell culture media is expanding following the dramatic growth in the demand for biopharmaceuticals centered around antibody drugs and the increasing need for treatments using cells, and its annual growth is expected to be approximately 10% going forward,” the company said in its official announcement. Click here to view the major deals in March 2018 (FREE Excel version available) Our View The first quarter of 2018 has shown a relentless rise in dealmaking as an outcome of increased liquidity in the financial markets, new technological breakthroughs, dwindling new drug pipelines of major pharmaceutical companies, an aging population along with rising health consciousness among consumers is expected to further propel dealmaking in the world of pharmaceuticals. With Pfizer always on the lookout, the upcoming quarter may just eclipse the records we’ve seen set in the first three months of the year. Click here to view the major deals in March 2018 (FREE Excel version available)

Impressions: 2473

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#PharmaFlow by PHARMACOMPASS

19 Apr 2018

FDA announces generic drug user fees for FY18; Gilead acquires Kite for US$ 12 billion

This week, Phispers brings you the FY18 user fee schedule under GDUFA II, posted by the USFDA, with significantly higher fee for several applications. There is news on an old drug getting approved for treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease, and a new study revealed benefits of blood thinners — Xarelto and Brilinta. Meanwhile, Gilead acquired Kite Pharma to access a new kind of cancer therapy. Read on. USFDA announces generic user fees for FY18; ANDAs, APIs, devices to pay higher fee This week, the US Food and Drug Administration (FDA) posted the FY18 user fee schedule for the Generic Drug User Fee Amendments. Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) applications to market generic drugs, known as abbreviated new drug applications (ANDAs), will see fee increases of more than US$ 100,000 — from US$ 70,480 in 2017 to US$ 171,823 in 2018. The fees were set based on negotiations between the pharmaceutical industry and the USFDA as part of a new five-year reauthorization of the FDA user fee programs signed into law earlier this month. In the fee schedule, a US$ 15,000 foreign differential applies to all non-US facilities, for both finished dosage form (FDF) and active pharmaceutical ingredients (API). This is the first year when pure CMO (contract manufacturing organization) facilities will pay a ‘reduced’ facility fee — one-third of the fee for a non-CMO. This year an ANDA holder fee, also known as program fee, was introduced. This fee has three tiers: entities that hold 20+ approved ANDAs, entities that hold six-19 approved ANDAs, and entities that hold one to five approved ANDAs. ANDAs pending approval are not added to this count, just as facilities that are only referenced in pending ANDAs are not subject to a facility fee. GDUFA II fee for FY 2018 in US dollar One-time application fee ANDA 171,823 DMF 47,829 Recurring fee for facilities Domestic API facility 45,367 Foreign API facility 60,367 Domestic FDF facility 211,087 Foreign FDF facility 226,087 Domestic CMO facility 70,362 Foreign CMO facility 85,362 Recurring GDUFA program fee (20+ANDAs) Large size operation generic drug applicant program 1,590,792 (6-19 ANDAs) Medium size operation drug applicant program 636,317 (1-5 ANDAs) Small business generic drug applicant program 159,079 The fee is applicable from October 1, 2017, until September 30, 2018. Decades old drug — amantadine — wins FDA approval to treat dyskinesia in Parkinson’s Adamas Pharmaceutical got the nod from the USFDA last week to sell its therapy ADS-5102 — an extended-release version of the generic amantadine. The agency approved it for treatment of a side effect (dyskinesia) caused by a commonly prescribed Parkinson’s drug — levodopa. Amantadine was able to beat a placebo in significantly reducing the side effects of levodopa. This generic drug is already used off label for dyskinesia. This is the first drug cleared by the FDA to control levodopa-induced dyskinesia (LID). According to Adamas, around 200,000 people in the US suffer from LID. LID leads to involuntary movements, mostly non-rhythmic, purposeless and unpredictable, making life all the more difficult for a patient of Parkinson’s disease. The disease is progressive and debilitating, causing tremors, rigidity, extreme slowness of movement, impaired balance, and difficulties in swallowing and speaking. After GSK, Novartis picks its chief digital officer from retail; Pfizer’s swanky new HQ Last month, GlaxoSmithKline appointed former Walmart chief information officer — Karenann Terrell — as its chief digital and technology officer. And last week, Swiss drug major Novartis followed suit — it appointed Bertrand Bodson, who is currently the chief digital and marketing officer for Sainsbury’s Argos retail chain, as its new chief digital officer. Bodson will assume office on January 1, 2018. These two appointments point to the growing challenges drug companies face from the digital world. For instance, mobile applications offer patients new ways to monitor their health. And clinicians increasingly communicate with their patients using the digital media. Bodson’s appointment is also an indication that Novartis intends to use technology for nearly everything — from drug discovery to interactions between clinicians and patients around the world. Bodson’s job also entails automating business processes. Bodson holds a degree from the Harvard Business School. He has also co-founded the social network site — bragster.com. Pfizer’s new HQ in New York: Pharma giant Pfizer has chosen the skyscraper — The Spiral — for its new headquarters in New York. The Spiral is a 1,005-foot-tall office tower in the Hudson Yards district of Manhattan’s Midtown West. According to New York Post, Pfizer has taken up nearly 800,000 square feet of space in this building. The 65-story, 2.85-million square-foot building is designed by Danish architect Bjarke Ingels. FDA approves first CAR-T therapy for cancer; Gilead bets big on it by acquiring Kite California-headquartered biopharma company Gilead Sciences is acquiring Kite Pharma for US$ 11.9 billion. The acquisition points to Gilead’s increased focus on a new kind of cancer therapy, known as chimeric antegen receptor (CAR) T-cell therapy (or CAR-T) According to Gilead, Kite is an industry leader in cell therapy — a treatment that uses the patient’s own immune cells to fight cancer. Kite’s most advanced CAR-T therapy candidate, axicabtagene ciloleucel (axi-cel), is currently under priority review by the USFDA. The FDA has set a target action date of November 29, 2017 under the Prescription Drug User Fee Act (PDUFA). For Gilead, Kite could bring in the much-needed growth. Gilead has been witnessing falling sales of its hepatitis C treatments. It generates most of its sales from anti-infective therapies. Therefore, the acquisition will diversify Gilead’s portfolio. It will also boost Gilead’s emerging oncology drug franchise. For the biotech sector, this acquisition is a big endorsement of the immuno-oncology segment. CAR-T inhibitors allow doctors to create a “personalized” drug tailored to each cancer patient by harvesting their T-cells and modifying them in a laboratory to make them more efficient at combating and killing cancer cells. Though critics say Gilead has overpaid for Kite, Gilead’s CEO, John Milligan, justified the purchase. “It is certainly our hope that as we are able to drive down manufacturing costs, and as or if these indications broaden to larger patient populations, that we would be able to drive down the prices over time through manufacturing efficiency,” he said. “CAR-T has the potential to become one of the most powerful anti-cancer agents for hematologic cancers,” Arie Belldegrun, president and CEO of Kite, said. Just days after Gilead’s announcement of its acquisition, the FDA approved Novartis’ Kymriah (tisagenlecleucel), the first CAR-T gene therapy, for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). The list price of Kymriah is US$ 475,000 for a one-time treatment. Bayer-J&J, AZ post promising data on their blood thinners; AZ to expand UK operations At the annual meeting of the European Society of Cardiology held in Barcelona this week, studies brought to fore several benefits of blood thinners like Johnson & Johnson and Bayer’s Xarelto, and AstraZeneca’s Brilinta. A study published in the New England Journal of Medicine revealed that the combination of a low dose of Xarelto and aspirin cut the risk of heart attacks by 14 percent, strokes by 42 percent, and death by 18 percent. Forty-one out of every 1,000 people who took the Xarelto-and-aspirin combo would be expected to have a heart attack, stroke, or heart-related death compared to 54 among those who got aspirin alone. Next generation anticoagulants, such as Eliquis, had been giving Xarelto a run for its money. Similarly, a sub-analysis from the Pegasus clinical trial, which first reported positive results in 2015, showed that AstraZeneca’s blood-thinner Brilinta cuts the risk of cardiovascular death by 29 percent in patients with a history of heart attacks who keep taking it beyond the standard 12-month initial period. The sub-analysis also showed a risk reduction of 20 percent in all causes of death. The finding comes as a shot in the arm for AstraZeneca, which had suffered several clinical failures last year. AstraZeneca to invest in UK facility: Meanwhile, AstraZeneca is making huge investments into its Macclesfield campus in England in order to ramp up production. This is Astra’s biggest manufacturing site. The investment — expected to run into tens of millions of pounds – is set to be announced soon. This investment is likely to take investors by surprise. A month back, Astra’s CEO Pascal Soriot had said he is putting all capital investment decisions on hold due to the uncertainty around Brexit. The decision comes amid calls for the UK government to do more to support the sector ahead of Brexit. Recently, drugmakers, including AstraZeneca, published a paper calling on the public sector to invest up to US$ 181 million (£140 million) in three new drug manufacturing “centers of excellence” to stimulate the industry and help reverse a long-term decline in UK’s drug exports.

Impressions: 2485

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#Phispers by PHARMACOMPASS

31 Aug 2017

GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

This week, Phispers brings to you the details of the bioelectronics firm formed by GSK and Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli Lilly, besides two other news snippets pertaining to the FDA -- while the first one pertains to generic approvals, the other one relates to an additional black box warning on a few antibiotics. GSK and Google join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life Sciences and GSK will together contribute US $ 715.12 million over seven years to the startup Galvani Bioelectronics. The startup will develop miniature electronic implants for the treatment of asthma, diabetes and other chronic conditions. The implantable devices developed by Galvani, which is owned 55 percent by GSK and 45 percent by Verily, can modify electrical nerve signals. The aim is to modulate irregular or altered impulses that occur in many illnesses.The new company will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK has been working on bioelectronic medicines since 2012 in a push to develop new patentable treatments, since its Advair respiratory treatment faces competition from generic versions. It has invested US $50 million in a venture capital fund for bioelectronics and provided funding to scientists working in the field. Teva divests 79 products to 11 generic players to close Allergan dealTeva Pharmaceutical Industries – the world’s largest generics drug company – won a US anti-trust approval to purchase Allergan's generics business, after agreeing to divest 79 generic drugs to rival firms. This was arrived at to settle Federal Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The companies that have acquired the divested products are Mayne Pharma Group, Impax Laboratories, Dr Reddy’s Laboratories, Sagent Pharmaceuticals, Cipla Limited, Zydus Worldwide DMCC, Mikah Pharma, Perrigo Pharma International, Aurobindo Pharma USA, Prasco and 3M Company. Eli Lilly CEO steps down; company under probe by US Justice Department Eli Lilly CEO John Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter has been the company's CEO since April 1, 2008, and the chairman of its board of directors since January 1, 2009.The announcement has come at a time when Eli Lilly has been asked by the Justice Department to disclose information on relationships with pharmacy benefits managers (PBMs), the companies that negotiate prices and set reimbursement conditions.It has not been clear what exactly the department of justice is looking for. In the past, drug makers such as Novartis and AstraZeneca have agreed to pay fines and penalties to settle allegations pertaining to PBMs. FDA continues to race ahead with generic approvals The American regulator has reduced its pile of ANDA (abbreviated new drug applications) by about 500 applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This news comes after Bloomberg reported last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass had reported last week that Indian companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark In regulatory news from across the world, Jinan Jinda, a Chinese API manufacturer that had failed an inspection by Italian regulators in June 2015, had more bad news awaiting it a year on. In a June 2016 re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In the June 2015 inspection, the critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall.Meanwhile, the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements. Another black box warning added to antibiotics like Cipro and LevaquinThe FDA has upgraded warnings on certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets and Merck’s Avelox. The FDA had added a black box warning in 2008 about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed. In May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has said it plans to build a new pipeline of drugs. It plans to revamp its research operations at the cost of around US $ 727 million.. The company also plans to close some of its R&D operations in the UK. Takeda is beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement.

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04 Aug 2016

Will data integrity concerns on clinical trials done at GVK Biosciences go beyond Europe?

Over 700 commonly used generic medicines were recommended for suspension by the European Medicines Agency (EMA) based on data integrity concerns, over clinical studies conducted at GVK Biosciences in Hyderabad, India.What will be the global fallout of the European decision? The European decision has impacted products from companies such as:Abbott Laboratories, Accord Healthcare (Intas), Actavis, Alembic, Apotex, Betapharm (Dr. Reddy’s), Brown & Burk UK, Fair Med Healthcare AG, Glenmark, Lupin, Micro Labs, Mylan, Orion Corporation, Ranbaxy, Ratiopharm, Sandoz, Sanofi-Aventis, Stada, Teva, Torrent, Wockhardt, Zydus… and many, many more.The original recommendation of suspending some of the medicines made in January 2015, was an outcome of an inspection of GVK Biosciences’ site in Hyderabad (GVK BIO is a Clinical Research Organization- CRO) by the French medicines agency (ANSM) through the EMA. The EMA stated in their official release: “The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials at the site.” 1000 drugs reviewed// 700 rejectedWhile over 1,000 pharmaceutical forms and strengths were reviewed at the GVK site, over 300 of them had sufficient supporting data available from other sources. As a result, these medicines were allowed to remain on the market in the EU.However, for the over 700 other medicines, the EMA after its second review, maintained its previous recommendation of January 2015, to suspend medicines, where no additional supporting data from other studies was available. Only one exception after that second review was spared from suspension, as the company was able to address the EMA’s concerns: it was Bivolet Nebivolol (5 mg tablets/ marketing authorisation holder: Neo Balkanika EOOD).While the agency noted that “there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad. Some of these medicines may remain on the market” if they are of critical importance for patients. However, the recommendation will now be sent to the European Commission for a legally binding decision, which will apply to Member States regardless of the decision taken in the interim period.The updated list of medicines for which, the CHMP (Committee for Medicinal Products for Human Use) recommends suspension, is available on the EMA website. Companies are given 12 months to submit additional data. The potential global impact of the European suspensions?The GVK Biosciences scandal is almost as severe in magnitude and impact, as the data falsification concerns, which were discovered at Ranbaxy (Katherine Eban’s stunning investigation in Fortune, “Dirty Medicine” covers this extensively). One of the main promoters of GVK Biosciences is Mr. D.S. Brar who was CEO & Managing Director of Ranbaxy from 1999-2004. The impact of GVK Biosciences’ misdeeds is already being felt on new product launches. Mylan recently withdrew its European application for generic Abilify (aripiprazole) (2014 sales US$6.2x billion) citing “identification of major GCP issues (Good Clinical Practices).” What about the impact on the US market?In 2010, FDA discovered data integrity violations, which bankrupted clinical research organization, Cetero Research/PRACS. Based on the Cetero findings in the United States, the EMA suspended seven drugs. Now it remains to be seen, how the FDA will handle the data integrity concerns found in Europe since products like repaglinide & candesartan cilexitil (Mylan), levetiracetam (Dr. Reddy’s), clonazepam (Sandoz), metformin hydrochloride (Actavis), tacrolimus (Panacea Biotech) all have U.S. FDA approvals. Leading GVK Biosciences’ defense is the Indian government, who warned last month that if the European Union does not reconsider their decision, it may go to the World Trade Organization. The Indian government’s position is based on an appeal by GVK Biosciences, which made the “Indian government set up a panel of experts last year to investigate the matter and found no manipulation”, GVK Biosciences CEO Manni Kantipudi told Reuters.However, globally reputed GMP expert, Lachman Consultants, believes that the GVK Bioscience episode “could potentially impact data integrity, similar to the Cetero/PRACS case”.It’s clear for us that this is not the end of the story…

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28 May 2015

Teva and Otsuka’s Multi-Billion dollar plan when blockbusters turn Generic: Deuterium Chemistry

Two blockbusters, Otsuka’s Abilify® (aripiprazole) and Teva’s Copaxone® (glatiramer acetate), with combined sales of more than $10 billion in 2014 are going to face severe generic competition this year. Interestingly, both companies have turned to a new technology platform, which uses deuterium chemistry analogs of old, off-patent drugs to secure their future profits. A simple swap of six hydrogens with deuterium in an existing drug, Xenazine® (tetrabenzaine), resulted in an improved version of the drug, called deutetrabenzaine or SD-809. This improved version breaks down more slowly in the body, allowing physicians to give it less often and at lower doses. The worth was established, when Teva paid $3.5 billion for the company Auspex, which developed SD-809. SD-809 is expected to be approved in 2016 for the potential treatment of chorea (abnormal involuntary writhing movements), associated with central nervous system disorders like Huntington’s disease, tardive dyskinesia, and Tourette syndrome. Now, while this may have sounded like complex chemistry, you’ll be surprised by the simplicity of the concept. What is this deuterium that replaced the hydrogen? Deuterium is a non-radioactive, stable and naturally occurring hydrogen isotope. The atomic mass of hydrogen is approximately 1.0 atomic mass unit (AMU), while that of deuterium is approximately 2.0 AMU. We all have 1-2g of deuterium in our bodies. Why does a deuterium swap make a difference? Replacing some hydrogen atoms with deuterium does not change the shape or electronic structure of the molecule, but it can make a big difference in how it behaves. The reason: chemical bonds formed with deuterium are generally stronger and longer-lasting than those with hydrogen. Stronger bonds allow for small molecule drugs to resist to metabolic enzymes in the body that break down weaker hydrogen bonds. The result: the drug is broken down slower in the body, stays longer and hence is not required in high doses or as often. In addition, the deuterated drug is more stable in the presence of other drugs, resulting in reduced drug-drug interactions. What did Teva & Otsuka buy? Teva: In addition to Auspex’s lead compound, SD-809, Teva also procured other pipeline candidates, which include deuterated versions of levodopa for Parkinson’s disease and pirfenidone for idiopathic pulmonary fibrosis. As Roche purchased InterMune® $8.3 billion last year needs to get changed to “As Roche purchase Intermune for $8.3 billion last year” Otsuka’s $3.5 billion acquisition of Avanir Pharmaceuticals involved a pipeline of products, which are combinations of common, cough syrup ingredient, dextromethorphan with an old-heart drug, quinidine. The promise of deuterated dextromethorphan for Alzheimer’s disease (Avanir compound AVR-786) was a key driver for Otsuka to purchase Avanir. The challenges and opportunities It can be difficult and not always clear to figure out where exactly to swap the deuterium for maximum effect. Legally, a deuterated compound is only considered a new drug if there is sufficient difference in the “active moiety” structure because initially the FDA had considered tetrabenzaine and deutetrabenzaine (SD-809) to be the same drug! However, deuterium chemistry, while simple, requires specialization, which serves as an opportunity for chemical companies to consider developing. With almost $7 billion in acquisitions in under 6 months, deuterium chemistry does deserve attention.

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21 May 2015

Find PharmaFlow Article for Prestwick3_000017

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Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

33 API Suppliers

20 USDMF

13 CEP/COS

4 JDMF

2 EU WC

9 KDMF

12 NDC API

14 Listed Suppliers

DEVELOPMENTS

34 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

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INTERMEDIATES

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DOSSIERs // Finished Dosage Formulations

316 Dossiers

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122 Europe

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TABLET;ORAL - 10MG;100MG

TABLET;ORAL - 25MG;100MG

TABLET;ORAL - 25MG;250MG

TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 12.5MG;200MG;50MG

TABLET;ORAL - 18.75MG;200MG;75MG

TABLET;ORAL - 25MG;200MG;100MG

TABLET;ORAL - 31.25MG;200MG;125MG

TABLET;ORAL - 37.5MG;200MG;150MG

TABLET;ORAL - 50MG;200MG;200MG

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TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons