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This week was a busy one, particularly for the pharma sector in India. Pharmaceutical Whispers (Phispers) shares Sanofi’s billion-dollar bet on ending the use of injections, India’s ban on over 300 fixed dosage combination drugs, the fake Harvoni scandal in Israel, AstraZeneca shareholders’ wrath over CEO’s remuneration and a lot more
Sanofi to spend billions to find new oral medicines to replace injections
France’s biggest drug-maker, Sanofi could pay as much as $2.3 billion to privately held DiCE Molecules in a partnership deal that aims to find new oral medicines to replace injections for certain diseases. The companies intend to work on as many as 12 drug targets.
Monoclonal antibodies, the biggest revenue earners for major pharmaceutical companies, are administered by injection or infusion. DiCE believes its technology should enable monoclonal antibodies to be replaced by orally-administered medicines.
India bans sale of over 300 fixed dose combination drugs
Last weekend, India’s health ministry banned 344 drug combinations, including several antibiotics and analgesics. Market researcher AIOCD AWACS estimated the FDC ban could cut sales in the local pharmaceutical industry by up to US $ 522 million, with Pfizer and Abbott among the worst hit.
A government-appointed panel of experts found the combinations lacked “therapeutic justification”.
The ban included drugs like Procter & Gamble’s Vicks Action 500 Extra, Abbott Laboratory’s Phensedyl and Pfizer’s cough syrup – Corex. P&G’s Indian business plans to challenge the ban on Vicks Action 500 Extra. While it had stopped selling the product, P&G was evaluating all options to challenge the ban.
Meanwhile, Delhi High Court granted US drug maker Pfizer an interim injunction on the ban on Corex.
Court dismisses Ranbaxy whistleblower’s plea for safer drugs in India
Another big news from India last week was the Supreme Court’s dismissal of public interest litigations (PILs) filed by former Ranbaxy executive Dinesh Thakur. The whistleblower had challenged certain rules under the Drugs and Cosmetics Act and had sought “the creation of a framework for the recall of drugs and a commission to examine faulty drug approvals”.
The Bench questioned the locus standi of the petitioner. “An overseas citizen has come all the way to challenge a rule. What is your locus?” the judge asked and further added, “Bring a public person affected by the rule.”
Subsequently, the Delhi High Court issued an interim order in favor of Pfizer for Corex, as mentioned in the previous news brief. These two cases also highlight the challenges and frustrations faced by the industry and the regulators in India, impeding domestic market growth.
GW Pharma’s drug made from marijuana aces clinical trials
In July last year, PharmaCompass had highlighted how GW Pharmaceuticals – a UK based company – was developing medicines from marijuana. Their product, Sativex (approved in 27 countries), is currently awaiting US Food and Drug Administration (FDA) approval.
This week, we heard the news that GW Pharma had conducted a 120-patient trial, which showed patients taking Epidiolex (a drug for severe epilepsy or Dravet syndrome, made from marijuana) had achieved a median reduction in monthly convulsive seizures of 39 percent compared with a reduction on placebo of 13 percent.
The study of GW's Epidiolex in Dravet syndrome is the first of four final-stage Phase III epilepsy trials, with results expected this year, that the drug maker hopes will confirm the therapeutic benefits of cannabinoids (the class of active ingredients found in marijuana).
Fake Harvoni found in Israel traced back to Indian manufacturer
Fake Harvoni scandal rocked the pharma world last week. Harvoni – a combination of ledipasvir and sofosbuvir – is Gilead Sciences’ blockbuster Hepatitis C drug which had almost $14 billion in sales in 2015.
A Swiss importer had supplied fake Harvoni to Israel. The importer said it bought the drug from an Indian manufacturer. Earlier this month, plastic bottles, which originated in India, were imported by a Swiss trading company and contained white instead of genuine yellow film-coated tablets.
The Swiss agency for therapeutic products – Swissmedic – is working with other European authorities to establish whether Harvoni packs with counterfeit contents have also been imported into other countries. Swissmedic is currently investigating the incident in collaboration with Indian regulators.
AstraZeneca faces shareholder outrage over GBP 8.4 million CEO pay package
AstraZeneca faced an embarrassing revolt by its shareholders over CEO Pascal Soriot’s pay package. Soriot’s pay more than doubled to GBP 8.4 million (US $ 11.8 million) last year, with about half of this coming from shares vesting under a long-term incentive plan.
Investors are upset by the board’s refusal to link Soriot’s pay to the ambitious targets set out when AstraZeneca rejected a US $ 118 billion takeover bid by Pfizer two years ago. A number of AstraZeneca’s biggest shareholders are now planning to vote against Soriot’s remuneration at the annual meeting next month. The revelation came barely a month after AstraZeneca issued a profit.
Meanwhile, AstraZeneca’s board committee said it is looking at ways to clearly link executive compensation to a US $ 45 billion revenue target.
At the same time, Horizon Pharma received a total compensation of $93 million in 2015.
Biogen’s multiple sclerosis drug Tecfidera loses European patent
A European Union court has revoked a patent covering 480-mg-per-day dose of Tecfidera, which was first launched in 2013. Tecfidera (a multiple sclerosis drug) had made it to PharmaCompass’ list of top 20 drugs of 2015 posted last week.
The patent, which expires in 2028, is one of four that Biogen holds on Tecfidera in the EU, along with a 10-year period of market exclusivity due to its classification as a “new active substance.” Biogen is likely to appeal the decision, which would suspend the revocation for as long as four years, as the court battle goes on. Tecfidera is Biogen’s top-selling drug.
To address price gouging, FDA will prioritize review of 125 generic drug applications
The FDA has said it will prioritize review of new applications for generic drugs that would compete with treatments made by only one company. The FDA estimates this change in prioritization could expedite review of as many as 125 generic drug applications.
Such a regulation could make it less profitable for someone like Martin Shkreli (who until last year was the CEO of Turing Pharmaceuticals) to buy old, patent-expired drugs with no competition and hike their price. Shkreli had acquired Daraprim, a decades-old anti-parasitic treatment, and increased its price to US $ 750 a pill from US $ 13.50.
This news comes at a time when Express Scripts, the pharmacy benefit manager in the US, reported that it had significantly controlled drug costs and “kept the increase in drug spending to just 5.2 percent in 2015, roughly half the increase seen in 2014”.
GSK faces class action lawsuit in Australia over prescribing anti-depressants to children
There is trouble brewing for GlaxoSmithKline (GSK) in Australia. A Sydney law firm has launched class action on behalf of people who as children and adolescents were prescribed the anti-depressant drug Paroxetine. The firm has called for expressions of interest from people who were prescribed the drug, commonly known as Aropax in Australia, when they were 18 years or younger.
In 2001, GSK (then SmithKline Beecham) had funded a trial of the drug that showed Paroxetine was safe for use in adolescents. However, in 2004, a sub-committee of the Australian Drug Evaluation Committee had said it posed risk of increased suicidal ideation and self-harm among children and adolescents.
Doctors Without Borders challenges Pfizer's pneumonia vaccine patent in India
Last week, Medecins Sans Frontieres (MSF) – an international humanitarian organization (also known as Doctors Without Borders) filed a patent opposition in India to prevent US pharma behemoth Pfizer from getting a patent on the pneumococcal conjugate vaccine marketed as Prevenar, in order to encourage the availability of affordable versions of the vaccine in developing countries and to humanitarian organizations.
This is the first time a vaccine (biosimilar) patent has been challenged in India by a medical organization. MSF says Pfizer has priced Prevenar too high – “it is now 68 times more expensive to vaccinate a child than in 2001”.
Deaths caused by Gilead’s Zydelig halts clinical trials
Both the US FDA and the European Medicines Agency (EMA) have raised concerns over increased rate of adverse events, including deaths, in the clinical trials of Gilead’s cancer medicine Zydelig (idelalisib).
The drug is authorized in the EU to treat two types of rare blood cancers called chronic lymphocytic leukaemia and follicular lymphoma. Gilead confirmed it is stopping six clinical trials in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas.
Zydelig witnessed sales growth from $23 million to $109 million in 2015.
Manufacturing highlights - Hovione announces pact with Vertex, Corden expands capacities
Hovione announced it plans to host and operate a commercial-scale continuous manufacturing facility as part of an agreement with Vertex Pharmaceuticals. The state-of-the-art facility will be installed in Hovione’s New Jersey location. Hovione expects the project to be complete by 2017-end.
Corden Pharma has completed two additional key investments that would strengthen its development and manufacturing capabilities for drug product service offerings across its highly potent, oncology and injectables platforms.
Valeant $600 million earnings typo, potential debt default makes market value crash almost 50 percent
Six months ago, Valeant Pharmaceuticals was the darling of the stock market and valued as one of Canada’s most valuable companies with its stock trading at C$ 350.
The Canadian drug-maker, the target of several U.S. investigations into its business and accounting practices due to allegations that it inflated revenues of its dermatology business, had delayed its earnings call.
However, this week when it announced its projected earnings, the company cut their 2016 revenue forecast by about 12 percent and said a delay in filing its annual report could pose a debt default risk.
On a terrible day for Valeant, they also made a major error in their press release, forecasting profits of up to $6.6 billion, when its presentation expected only $6 billion for the following four quarters.
Valeant’s market value crashed almost 50 percent and its shares were trading at about C$ 46 on Tuesday.
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