(-)-Cannabidiol
CDMO Activity Tracker: CDMOs expand operations in cell and gene therapies, biologics, HPAPIs
The Covid-19 pandemic expedited the growth of contract development and manufacturing organizations (CDMOs) as pharma companies increasingly turned to them to accelerate drug development. However, by the end of 2022, a decline in demand for Covid vaccines hit some CDMOs, and they saw their supply deals come to an abrupt end.The year 2022 also saw the steepest drop in new drug approvals by the US Food and Drug Administration (FDA) since 2016. Although the Center for Drug Evaluation and Research (CDER) only approved 37 new drugs, a 26 percent decline from the 50 drugs approved in 2021, there was a rise in new biologic drug approvals. Of these, 41 percent were biologics. Eight biologics were also approved by FDA’s Center for Biologics Evaluation and Research (CBER) in 2022.Despite other challenges like high inflation, the ongoing Russia-Ukraine war and increasing economic uncertainties, CDMOs continued to grow through 2022 and the first quarter of 2023, particularly in biologics, cell and gene (C&G) therapies and highly potent active pharmaceutical ingredients (HPAPIs).CDMOs have been swift in altering their production lines to meet the demands of smaller, more diverse projects. This flexibility is likely to contribute to future growth. According to Research and Markets, the global CDMO market was valued at US$ 172.7 billion in 2022, and is projected to reach US$ 246.6 billion by 2026, growing at a CAGR of 9.3 percent.View CDMO Activity Tracker of Q1 2023 (Free Excel Available)Large CDMOs post double-digit growth; Sartorius buys Polyplus for US$ 2.6 billionSeveral big CDMOs such as the Lonza Group, Samsung Biologics and Siegfried AG reported impressive revenue growth in 2022. Switzerland-based Lonza, the biggest CDMO player, saw its revenue grow 15 percent to reach CHF 6.2 billion (US$ 6.7 billion) in 2022.Samsung Biologics’ CDMO revenue skyrocketed 49 percent in 2022, as compared to 2021, touching KRW 2.34 trillion (US$ 1.85 billion). Siegfried generated CHF 1,229 million (US$ 1.33 billion) in sales, a growth of 15.6 percent. And EUROAPI’s CDMO business grew 18.3 percent to reach € 267.5 million (US$ 0.28 billion). Meanwhile, Pfizer CentreOne generated US$ 1.34 billion in sales in 2022. As demand for Covid jabs dropped, Catalent announced structural changes and cost-reduction measures, including more than 210 layoffs at its Texas and Maryland facilities. It also laid off up to 400 employees at its Bloomington, Indiana site. Overall, Catalent’s revenues grew by 1 percent — at US$ 2.17 billion — in the last six months of 2022. Similarly, UK-based CDMO Abzena also laid off 66 employees in San Diego.So far, the biggest CDMO deal of 2023 has been the acquisition of France-based Polyplus, a provider of innovative upstream technologies for advanced biologic and C&G therapy production, by Germany-based CDMO Sartorius Stedim Biotech for €2.4 billion (US$ 2.6 billion). The deal gives Sartorius the know-how needed in the production of viral vectors for building C&G therapies.View CDMO Activity Tracker of Q1 2023 (Free Excel Available) Catalent expands into cell therapies, Charles River Labs signs deal with RznomicsThe development of C&G therapies has emerged as a high growth area for CDMOs. In 2022, CSL’s hemophilia B treatment Hemgenix emerged as the world’s most expensive medicine, beating Bluebird bio’s C&G therapies — Skysona and Zynteglo. This year, around 13 C&G therapies are expected to receive approval in the US and Europe, offering big opportunities to CDMOs worldwide. The US$ 3.2 billion CDMO market for C&G therapies is estimated to be growing at 18.1 percent CAGR, and is poised to reach US$ 18.6 billion by 2032.In January, Catalent opened a new plasmid DNA manufacturing facility in Belgium for cell therapies and expanded its partnership with Sarepta for manufacturing its gene therapy candidate  — SRP-9001. If approved, this could be the first gene therapy for Duchenne muscular dystrophy (DMD). Catalent has also entered into a licensing agreement with Bhami Research Laboratory to access the latter’s formulation technology to help enable the subcutaneous delivery of high-concentration biologic therapies.Charles River Laboratories has signed a deal with South Korean biopharma Rznomics to develop and manufacture viral vectors for a gene therapy to treat liver cancer. It also inked another deal with Purespring Therapeutics for plasmid DNAs and acquired SAMDI Tech for US$ 50 million. In recent years, the company has expanded its C&G portfolio through the acquisitions of Cobra Biologics, Vigene Biosciences and Cognate BioServices.View CDMO Activity Tracker of Q1 2023 (Free Excel Available) Samsung Biologics, LOTTE, Lonza expand facilities for ADCsThe other emerging growth area for CDMOs is biologics. The global CDMO market for biologics was valued at US$ 11.27 billion in 2021 and is expected to grow at 11.51 percent CAGR to reach US$ 21.90 billion by 2027. Technological advancements and approval of new biologic drugs is contributing to this growth.Biologics are triggering deals. After Provention Bio received FDA approval for its type 1 diabetes drug Tzield last year, the US-based company signed a deal with AGC Biologics in January this year to produce the drug at its Seattle biologics plant. Last month, Sanofi announced it is acquiring Provention Bio for US$ 2.9 billion.Several CDMOs are also vying for a share of the fast growing antibody-drug conjugates (ADC) market, which is projected to reach US$ 13.1 billion by 2030, up from US$ 3.51 billion in 2020. Samsung Biologics’ CEO, John Rim, announced in January that ADCs would be a major focus area for the company. It is investing US$ 1.46 billion to construct its plant 5 for biopharmaceuticals and plans to start operations in 2025. It has also entered into a manufacturing deal with Pfizer for US$ 183 million.Newly-established CDMO LOTTE Biologics is also expanding its facility for ADCs in order to get a foothold in North America. LOTTE Biologics plans to invest US$ 3 billion over the next seven years to build three mega plants. It has also acquired BMS’ manufacturing facility in New York for US$ 160 million. Similarly, Lonza completed the expansion of its facility for ADCs in Visp, Switzerland.View CDMO Activity Tracker of Q1 2023 (Free Excel Available)Growing demand for HPAPIs, controlled substances draw investments in CDMOsThe global market for HPAPIs is growing at 8.5 percent CAGR and is expected to reach US$ 34 billion in 2026. Several companies have announced expansion plans to meet this rising demand.Piramal Pharma Solutions has started production of APIs and HPAPIs at its facility in Michigan, US. German CDMO ChemCon provides services for APIs, HPAPIs and controlled substances, including amphetamines, cannabinoids, fentanyl derivatives and steroids. Additionally, it offers high-quality fine chemicals, isotopically labeled compounds, organic, inorganic and polymer chemistry. Its products are used for important specialty applications such as oncology, orphan diseases, critical care, dermatology, etc. Veranova’s subsidiary Macfarlan Smith has completed a US$ 10 million expansion of its mid-scale API manufacturing capabilities in Edinburgh, UK. Siegfried has opened a development center for drug products in Barcelona, Spain, with dedicated facilities for HPAPI products. Last November, Polpharma announced investment at its HPAPI facility in Poland. It expects to open a new R&D and production facility in the first quarter of 2024. Meanwhile, Eurofins CDMO Alphora Inc has also expanded its API development laboratories, including those for HPAPI development.CDMOs are also expanding their services for controlled substances, particularly in therapeutic areas such as depression, PTSD, addiction and pain management. Due to stringent regulations on the development and manufacture of controlled substances, pharma companies are turning to CDMOs that are experienced and licensed to handle them. These include Cambrex Corporation, Curia, Patheon, Pfizer CentreOne, Veranova, ChemCon, Evonik, Minakem and Seqens.View CDMO Activity Tracker of Q1 2023 (Free Excel Available)Our viewOver the last few years, we have noticed how CDMOs have altered their business models with changes in the business environment. Of late, CDMOs have benefitted from the trend of smaller biotechs outsourcing manufacturing of novel modalities, such as C&G and RNA therapies. Of the 37 drugs approved by the FDA’s CDER last year, 24 (or 65 percent) were developed by mid or small-sized biopharma companies.We also know how the approval of new drugs benefits the CDMO industry. For instance, FDA approved Rigel Pharma’s Rezlidhia (olutasidenib) in December as a treatment for relapsed and refractory acute myeloid leukemia. The drug’s dose manufacturing has been outsourced to Catalent. Therefore, a rise in the approval of novel drugs in 2023 should benefit the industry. And rapid advancements in biotechnology will ensure healthy growth of CDMOs.

Impressions: 2777

https://www.pharmacompass.com/radio-compass-blog/cdmos-expand-operations-in-cell-and-gene-therapies-biologics-hpapis

#PharmaFlow by PHARMACOMPASS
13 Apr 2023
DMF submissions rise 12.1% in 2022; India sees 10.6% drop in Type II filings
In 2022, the world finally began to emerge out of Covid-related restrictions. Though 2020 and 2021 saw several travel-related curbs, there was no let up in the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA). In the four years between 2018 and 2021, the number of Type II DMF submissions (i.e. submissions for drug substance, drug substance intermediate, and material used in their preparation, or drug product) remained steady at over 630 per year.In 2022, the DMF submissions rose at an impressive pace of 12.1 percent. A total of 1,024 DMFs (Types II, III, IV and V) were submitted in 2022, as opposed to 913 in 2021.Last year, Type II DMF submissions increased by 7.2 percent — a total of 715 Type II DMFs were submitted in 2022 as opposed to 667 in 2021. However, of the 715 DMFs filed with the FDA, only 190 (26 percent) had their reviews completed.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) DMF submissions from India dip 10.6%, China’s filings increase 45%As always, DMFs filed from India and China were significantly higher than DMFs from other countries. However, the year saw DMF submissions from India drop by 10.6 percent. Overall DMF submission from India stood at 336, as opposed to 376 in 2021. In comparison, China’s DMF filings increased by 45 percent to 231 in 2022, as opposed to 159 in 2021. Interestingly, FDA had issued 31 Form 483s in 2022 out of which 15 were issued to Indian drugmakers. Out of 15, seven Form 483s were issued to manufacturing units belonging to four Indian API manufacturers — Lupin, Aurobindo Pharma, Torrent and Biocon Biologics.While DMFs are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products, a Form 483 is a notification sent by the FDA to a drugmaker regarding objectionable conditions at a facility. A Form 483 is issued at the conclusion of an inspection, when an investigator finds regulatory violations and/or non-compliance of good manufacturing practices. January 2023 saw a spate of Form 483s issued to Indian drugmakers, raising concerns within the pharma industry.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available)   India’s Metrochem API tops DMF submissionsIndia’s Metrochem API led the list of companies with the highest number of DMF submissions at 19. MSN Labs stood second with 16 submissions.Other top Indian companies were Aurobindo Pharma (15), Biophore India (15), Hetero Group (11) and Cipla (10), followed by two Chinese companies — BrightGene Bio-Medical Technology and Changzhou Pharmaceutical Factory — with 9 submissions each.The maximum number of DMF filings were for elagolix sodium (11), empagliflozin (eight), tofacitinib citrate (six), revefenacin (six), apixaban (five), brivaracetam (five), cannabidiol (five), followed by mirabegron (five) and tafamidis (five).A total of 79 DMFs were filed for the first time for 64 products, of which 28 had their GDUFA  (Generic Drug User Fee Amendments) review completed. These include revefenacin (six), migalastat hydrochloride (three), cupric sulfate (three), ivosidenib (two), upadacitinib (one) and voxelotor (one). Revefenacin is losing its marketing exclusivity this year.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available)   Our viewIn our last (H1 2022) review of DMF submissions, we had mentioned that less than half of the 350 Type II DMFs filed by the FDA had been reviewed, as the user fee program had not been reauthorized.FDA published the New GDUFA III fee structure at the eleventh hour — on September 30, 2022. GDUFA III includes several enhancements to the abbreviated new drug application (ANDA) assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality and affordable generics.With the GDUFA III, the US government has made clear its intent to lower generic drug prices. In future, more drugs are likely to go off-patent and we are likely to see the number of DMF submissions rise even further.In the second quarter of 2022, FDA resumed unannounced inspections in India. The regulator has also stepped up onsite inspections. FDA wants cheaper drugs, but not at the cost of quality. There are no short-cuts for generic and bulk drug manufacturers wanting to export to the US.(This article has been updated to accurately reflect the information on Metrochem API and MSN Labs.) 

Impressions: 2168

https://www.pharmacompass.com/radio-compass-blog/dmf-submissions-rise-12-1-in-2022-india-sees-10-6-drop-in-type-ii-filings

#PharmaFlow by PHARMACOMPASS
02 Feb 2023
Cannabinoids in pharmaceutical development
The development of cannabinoids in the pharmaceutical industry has exploded over the past few years. With the gradual liberation of regulations worldwide that govern cannabis and its pharmaceutical derivatives for medicinal use, this week PharmaCompass leveraged its Technology Prospector tool to develop a map of the global development landscape of these drugs. Technology Prospector is our proprietary technology. We scanned patents and journal publications, over the past five years, for cannabinoid-related content to identify the organizations which are developing products linked to the technology of interest. Click to view our Technology Prospector on Cannabinoids in Development Over the past two decades, there has been a resurgence of patient interest in using cannabis and cannabinoids to treat a variety of conditions, including chronic pain, cancer pain, depression, sleep disturbances and neurological disorders. This increased interest has resulted in a renewed scientific focus on the medical use of substances found in the cannabis plant, namely cannabinoids. The two most extensively studied ingredients in cannabis are tetrahydrocannabinol (THC) and cannabidiol (CBD). However, it is estimated that over 100 other cannabinoids and terpenoids in cannabis may also have medical uses. THC is known to produce the psychoactive effects sought by recreational users, such as euphoria, relaxation and heightened sensory experiences. There is also evidence to support the medical use of THC in controlling nausea and vomiting, stimulating appetite and reducing pain. CBD, on the other hand, may moderate the psychoactive effects of THC, while also reducing epileptic seizures. In the early 1990s, a cannabinoid system in the human brain and body was discovered that was responsible for the control of important biological functions, such as cognition, memory, pain, sleep and immune functioning. In view of this increased interest in cannabinoids, we are leveraging PharmaCompass’ Technology Prospector to provide an overview of the organizations actively involved in developing products linked to cannabinoids. Click to view our Technology Prospector on Cannabinoids in Development  Cannabinoid products on market   Several cannabinoid-containing medicinal products have been on the market for many years. Dronabinol (brand name: Marinol), a synthetic form of THC, got approved in 1985 for prevention of nausea and vomiting during chemotherapy and hauled in over US$ 100 million in annual sales. After the initial launch, the product also got approval for appetite and weight loss in patients with HIV/AIDS. In 1998, the product got reclassified from a Schedule II drug to a Schedule III drug by the Drug Enforcement Administration (DEA) in the US. In order to prevent drug abuse, the DEA has divided these substances into five categories (or Schedules) based on each drug’s (1) potential for abuse, (2) safety, (3) addictive potential and (4) whether or not it has any legitimate medical applications. The potential for drug abuse is the highest for Schedule I drugs and lowest for Schedule V drugs. Nabilone (brand names: Cesamet and Canemes) is a synthetic cannabinoid similar to THC. The main indication for its use is nausea and vomiting associated with chemotherapy, usually after previous treatments have failed. GW Pharmaceuticals’ Sativex, a mixture of equal quantities of THC and CBD from two cannabis extracts, is approved for sales in countries for the treatment of spasticity (muscle spasms and stiffness) related to multiple sclerosis — a disease that affects 1.3 million people worldwide, of which up to 80 percent suffer from spasticity. In 2018, the US Food and Drug Administration (FDA) approved GW Pharmaceuticals’ Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome.  The drug can be taken by patients aged two years and above. Click to view our Technology Prospector on Cannabinoids in Development  The battle of synthetic versus natural Cannabinoids   In order to win approval for Epidiolex, GW Pharmaceuticals set up giant greenhouses in the United Kingdom where it raises cannabis plants under highly controlled conditions. The plants are then made to undergo extraction and purification to crystallize pure CBD at GW’s facilities. There are other firms which are supporting production of cannabinoids via organic synthesis rather than extraction from the cannabis plant. There are already multiple Drug Master Files (DMF) submissions to the FDA for synthetic cannabidiol, as companies bet that the future of cannabinoid production will be from organic chemistry. Firms like Noramco and Johnson Matthey, which have conventionally been active in producing controlled substances from opium like morphine, codeine etc, have focused significant resources to meet the increasing demand for large-scale production of cannabinoids. While there are multiple technical challenges associated with scaling up organic synthesis processes, once overcome, they can usually meet growing market needs faster than processes dependent on plant extraction. However, GW has claimed the superiority of cannabinoid extracts over synthesized molecules. According to GW, cannabinoid ratios in the plant generate a complex chemical fingerprint which plays a critical role in therapeutic efficacy. While Epidiolex is more than 98 percent CBD, GW’s first product — Sativex — is a mixture of CBD and THC. However, to get regulatory approvals for synthetic cannabinoids maybe easier, since they have a well characterized starting material and a more precisely defined pathway that leads to more consistent manufacturing. Click to view our Technology Prospector on Cannabinoids in Development  New developments    As the developments on cannabinoids evolve rapidly, PharmaCompass’ Technology Prospector found over 200 organizations across 25 countries that had either patented or published work related to cannabinoids. The United States has the maximum active organizations followed by Canada, Israel and then Germany. Unsurprisingly, GW Pharmaceutical leads the count of patents filed. However, many major pharmaceutical companies such as Roche, AbbVie, AstraZeneca and Merck are developing products targeting the cannabinoid system in the human brain and body. To deliver cannabinoids, while companies like US-based Axim Biotechnologies are working on delivering cannabinoids via chewing gums to treat nausea, Hanyi Biological in China has patents on the delivery of cannabinoids as a toothpaste and mouthwash to treat irritable bowel syndrome. Botanix Pharmaceuticals is working on new treatment options for acne, psoriasis and atopic dermatitis, using a transdermal drug delivery system. There are also new manufacturing technologies being developed at companies like US-based Teewinot Life Sciences that have developed processes to manufacture cannabinoids using biocatalysis and established players like Noramco have signed an agreement with them. Click to view our Technology Prospector on Cannabinoids in Development  Our view   As government controls ease on the use of cannabis for scientific and medical purposes and there is a growing understanding that CBD should not be placed under international drug control because the substance does not have psychoactive properties, with no reported cases of abuse or dependence, there is clear evidence that the field will witness a lot more development activity in the years to come. PharmaCompass’ Technology Prospector, our proprietary technology to identify organizations which are developing products linked to the technology of interest, can be applied across a variety of capabilities. Email us at support@pharmacompass.com to learn more. Click to view our Technology Prospector on Cannabinoids in Development   

Impressions: 4560

https://www.pharmacompass.com/radio-compass-blog/cannabinoids-in-pharmaceutical-development

#PharmaFlow by PHARMACOMPASS
19 Dec 2019
Sales Forecast of FDA’s Novel Drugs Approvals in 2018
The year 2018 was a landmark year for the US Food and Drug Administration (FDA) as the agency approved a record number of novel drugs. FDA approved 62 novel drugs in 2018, out of which 34 were orphan drugs. FDA’s Center for Drug Evaluation & Research (CDER) approved 59 drugs while the other three were approved by the Center for Biologics Evaluation and Research (CBER). In a speech towards the end of the year, FDA Commissioner Scott Gottlieb said: “Far more important than the overall quantity of approvals however is the quality of the new drugs”. He went on to add that some “of [the] previous records were set in years when there were a lot of drugs that critics bemoaned were me-too medicines,” or novel chemical entities that addressed the same common, therapeutic targets. In 2018, FDA reversed three earlier drug rejections, approved the first cannabis-based drug, allowed the first ever RNA interference drug to market and gave the green light to Loxo Oncology/Bayer’s Vitrakvi (larotrectinib) which became the second anti-cancer drug (after Merck’s Keytruda) to bag an approval that treats cancer based on a biomarker across different types of tumors rather than the location in the body where the tumor originated. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Gilead’s Biktarvy tops our list for sales potential   PharmaCompass compiled the peak sales estimates of the new drugs approved in 2018 and in our compilation, Gilead’s antiretroviral treatment for HIV — Biktarvy — topped the charts with an estimated sales potential of almost US$ 5.3 billion followed by Vertex’s cystic fibrosis drug Symdeko that is expected to bring in US$ 2.75 billion. Alexion’s Ultomiris, Abbvie’s Orilissa, Novartis’ Lutathera and J&J’s Erleada are all expected to bring in more than US$ 2 billion for their companies at their peaks.  Although Loxo’s cancer drug, with an estimated US$ 860 million in peak sales, did not make it to the list of top 15 drugs in 2018 by sales potential, the company got purchased by Eli Lilly earlier this month for US$ 8 billion. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Pfizer won four approvals, Shire won three   For 2018, Pfizer led the approvals with four drugs that got the green light, followed by Shire with three drugs. Companies like AstraZeneca, Array Biopharma, Alynlam and Paratek Pharmaceuticals each won two drug approvals. Merck also had two approvals which were in cooperation with other companies. Amgen, Teva and Eli Lilly got their CGRP inhibitors for migraine prevention approved within a few months of each other. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 First cannabis-based drug bagged approval   Last year, FDA also approved Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome.  CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. And Epidiolex is the first marijuana-based drug to be approved in the US for epilepsy. It is produced by GW Pharmaceuticals. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 CBD does not cause intoxication. It is one of the hundreds of molecules found in marijuana and has been cited by scientists as a potential treatment for mental health issues. 2018 saw the launch of one-dose flu cure from Shionogi   In March 2018, Shionogi & Co Ltd.’s Xofluza — a pathbreaking drug that cures flu with just one dose — was approved in Japan. The drug is a treatment for influenza A and influenza B.  In October, the US Food and Drug Administration (FDA) also approved Xofluza (baloxavir marboxil). Xofluza is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 The single dose feature gives Xofluza an edge over other neuraminidase inhibitors like Tamiflu and Relenza. For example, Tamiflu typically requires two doses each day for five days. Therefore, there are nine more doses of Tamiflu required, as compared to the single-dose Xofluza. Shionogi aims to double the global market for flu treatment with Xofluza. “While the global market of flu drug is said to be about US$ 1 billion to US$ 1.5 billion, we want to expand it to around US$ 3 billion,” Shionogi CEO Isao Teshirogi said last year. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Though the FDA approval for Xofluza has been granted to Shionogi, Genentech (a member of the Roche Group which marketed Tamiflu, which is now a generic) will be marketing the medication in the US. Industry gets far lower returns from its drug launches   Gottlieb used Twitter to promote the progress of FDA’s review cycle. “In 2018, CDER met its PDUFA goal for 100 percent of the novel drugs approved – 95 percent of which on the first cycle – reflecting our efficiency in getting new therapies to patients quickly,” he tweeted. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 A ‘cycle’ is the time from when CDER accepts an application for a new drug until the agency decides whether to approve it or not. However, the record number of approvals doesn’t present the complete picture for the pharmaceutical industry. A study published in December by Deloitte highlighted that the industry is getting far lower average returns from its drug launches than ever before. While the costs to bring a drug to market have almost doubled in eight years to over US$ 2 billion, peak sales forecasts have halved to a little over US$ 400 million, the study said. Drug discovery reviews in the scientific publication Nature reached a similar conclusion. “Projected peak annual sales for new therapeutic drugs (NTDs) approved in 2018 total US$ 45 billion — lower than 2017’s US$ 58 billion — and the value of the average peak sales per product has continued to trend down to only US$ 720 million per drug in 2018, the lowest figure in almost a decade,” the publication said. “The decline is driven both by fewer blockbusters at the top end, as well as a proliferation of very small products at the bottom end. We believe the underlying driver of both these trends — more approvals but smaller markets per approval — is better understanding of biology fostering precision medicine,” it added. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Our view   After suffering brutal losses towards the end of 2018, wherein biotech was among the US stock market’s most oversold sectors and saw a decline of nearly 10 percent, this year the biotech sector has got off to the best start since 2012. Drug companies are continuing to innovate more targeted therapies, and Chinese companies are investing in developing new drugs. While the industry expects to see a lot more mergers and acquisitions in 2019, where smaller biotech companies get acquired by major pharmaceutical corporations, it is unlikely that the general trend of companies bagging more approvals for targeted therapies with a smaller peak sales potential is going to reverse anytime soon.  Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018  

Impressions: 7044

https://www.pharmacompass.com/radio-compass-blog/sales-forecast-of-fda-s-novel-drugs-approvals-in-2018

#PharmaFlow by PHARMACOMPASS
17 Jan 2019
Marijuana Based Medicines – highway to pots of gold
Legally cultivated cannabis, in some parts of the United States, resulted in a boom, which could never have been previously imagined. Just last year, there were so many growers that, in the state of Washington alone, more than 20,000 kg of marijuana (cannabis) was available, which didn’t have any takers!Last year also saw the stock market recognize the value of little known, GW Pharmaceuticals, a UK based company, focused on developing medicines from marijuana. Their product, Sativex, already approved in 27 countries is currently awaiting USFDA approval. With Wall Street valuing GW Pharmaceuticals at almost $2 billion, is there a future for marijuana based medicines? Increasing production of legal marijuanaMarijuana or cannabis, is ‘still’ classified as schedule 1 drug, which means that the Drug Enforcement Agency (DEA), believes there is no currently accepted medical use and the drug isn’t safe to use even under medical supervision. However, with all the research interest, the DEA has proposed a massive increase in the amount of marijuana production. It will hopefully allow, that the demands of the researchers will finally be met.  Highly curative?There are two key active ingredients inside Marijuana, Cannabidiol (CBD) and Tetrahydrocannabinol (THC). While the potency of marijuana is linked to the amount of Tetrahydrocannabinol (THC) inside it, Cannabidiol (CBD) which isn’t responsible for the high, is the one considered to have the wider scope for medical applications.  Epidiolex// treatment of epilepsy in children?An orally-administered liquid containing CBD has received orphan drug status in the US, under the brand name Epidiolex. GW Pharmaceuticals, the developer of Epidiolex is also performing their second Phase III clinical trial to demonstrate its effectiveness in the treatment of epilepsy in children. Sativex// treatment of spasticitySativex, a mixture of THC and CBD, is approved for sales in countries for the treatment of spasticity (muscle spasms and stiffness) related to multiple sclerosis; a disease that affects 1.3 million people worldwide, of which up to 80% suffer from spasticity.In addition to THC and CBD, GW Pharmaceuticals, has also developed a portfolio of products based on the other cannabinoids found in the plant. Marinol// approved in 1985GW Pharmaceuticals isn’t alone since synthetic derivatives of THC have also been on the market for years. Dronabinol (brand name: Marinol), approved in 1985 for prevention of nausea and vomiting during chemotherapy, is estimated to have current sales of almost $450 million. After the initial launch, the product also got approval for appetite and weight loss in patients with HIV/AIDS. The product got reclassified, in 1998 by the DEA, from a Schedule II drug to a Schedule III one which allowed access to a wider patient base. An open ‘high-way’ for businessInsys Therapetuics, another player in this space, who had their novel, more bio-available formulation of Dronabinol rejected by the FDA, still commands a market valuation of almost $3 billion. Plant based medicines, like Paclitaxel, Docetaxel, Morphine, Codeine have made billions for the pharmaceutical industry in the past and the market valuations of GW Pharmaceuticals and Insys Therapeutics indicates similar expectations for developing medicines from marijuana. With many other cannabinoids in the plant, raw material availability no longer as restricted as in the past, licensing opportunities on new indications available from the National Institute of Health (NIH)– it is just a matter of who hits the marijuana ‘high-way’ first? 

Impressions: 2221

https://www.pharmacompass.com/radio-compass-blog/marijuana-based-medicines-highway-to-pots-of-gold

#PharmaFlow by PHARMACOMPASS
16 Jul 2015