Seven of your Facilities are Out of Compliance, FDA Tells Wockhardt; Mylan's EpiPen Sales Crash

Seven of your facilities are out of compliance, FDA tells Wockhardt; Mylan’s EpiPen sales crash

In Phispers this week, there is news on how alternatives to Mylan’s EpiPen have eaten into its US sales. Warning letters posted by the FDA revealed that it considers seven of Wockhardt’s sites out of compliance and there is more trouble in the works for the former Ranbaxy promoters. And, Novartis faces punitive action in South Korea. Read on.

Mylan’s EpiPen sees drastic drop in market share in Jan-Feb 2017

Last year, Mylan was in the news for hiking the price of EpiPen by 500 percent. At that time, there were no generic avatars of the life-saving anti-allergy medicine available in the US market. But now, the scenario has changed. Data from athenahealth network shows that prescriptions for alternatives of Mylan’s EpiPen have “quadrupled since the beginning of 2017”.

More than 60,000 prescriptions for epinephrine auto-injectors, written for 50,000 patients by more than 1,400 healthcare providers in the US, were evaluated by researchers at athenahealth between January 2016 and February 2017. The share of alternatives to EpiPen have significantly increased in the last two months, as opposed to the end of 2016.

“At the end of 2016, EpiPen alternatives made up only 5.3 percent of prescriptions for epinephrine auto-injectors. By the last full week of February, that figure had grown to 28.9 percent,” athenahealth said.

The key reason for this sudden and significant shift is the lower price tags of the EpiPen alternatives. Most of these alternatives are priced at a fraction of the cost of Mylan’s EpiPen. Moreover, insurers could also be affecting the prescription patterns. In January this year, health insurance company Cigna began to cover only generic options to EpiPen.

Seven of your facilities are out of compliance, FDA tells Wockhardt

This week, US FDA posted the warning letter issued to Wockhardt's US-based Morton Grove facility. The concerns raised by the investigators ranged from Wockhardt's “investigations into out-of-specification (OOS) test results” that were found to be neither thorough, nor timely, nor based on scientific rationales” to the “original results” that were “invalidated without scientific justification under the protocol and only re-test results were reported as part of batch release decisions.”

Of serious concern is the fact that in the warning letter the FDA has said: "At this time, seven Wockhardt facilities (including Morton Grove) are considered out of compliance with cGMP. These repeated failures at multiple sites demonstrate your company’s inadequate oversight and control over the manufacture of drugs. In your responses to the various actions listed above, including during multiple meetings with FDA, you have repeatedly discussed and promised corporate-wide corrective actions. Yet, when FDA inspects or returns to other Wockhardt facilities, similar violations are shown to persist.”

Second FDA warning letter to Megafine over "calibration records in trash”

Megafine Pharma received its second FDA warning letter in less than a year for its facility which manufactures active pharmaceutical ingredient (API) intermediates. The Megafine plant in Vapi (Gujarat) was inspected last September and once again data integrity was the primary cause of concern raised by the FDA.

The facility was “issuing analysts with blank controlled document forms that had already been approved and signed”. Moreover, FDA investigators found torn, partially complete Quality Assurance-signed calibration records in the trash and saw QA staff shredding documents without reason.

In another observation, "analysts reprocessed data up to 12 times, and only included the final result in the report for review by Quality Assurance. Your Deputy Manager, Quality Control stated that it is common practice to ‘play with parameters’ to get the proper integration."

FDA investigators also noticed that the interior surfaces of the drug manufacturing equipment were not as clean as required.

Megafine's API plant in Lakhmapur, Nashik, was placed on FDA's Import Alert list in 2015.

Ghosts of Ranbaxy continue to haunt Singh brothers

Former promoters of Ranbaxy — Malvinder and Shivinder Singh — were directed by the Delhi High Court to seek its permission before selling any of their unencumbered assets. This puts in jeopardy reported plans of the brothers to sell their stakes in companies like Fortis Healthcare and Religare, although the court hasn’t passed an outright injunction against such an exercise.

The Singh brothers have also been directed to furnish details of all unencumbered assets in order to ascertain that they have enough funds to cover an arbitration payment of more than US$ 3.74 billion (Rs 250 billion) granted to Daiichi Sankyo by a Singapore tribunal last year.

The brothers have been engaged in a legal battle with Daiichi Sankyo, which bought out Ranbaxy in 2008 for US$ 4.1billion. Daiichi had accused the Singh brothers of misrepresenting the problems facing Ranbaxy when it acquired the firm. In 2014, Daiichi sold Ranbaxy to Sun Pharma.

Investors demand cut in new GSK CEO’s prospective pay package

A number of investors in Britain’s largest drug company — GlaxoSmithKline (GSK) — are reportedly putting pressure on its board to reduce a proposed multi-million pound pay deal for its new CEO, Emma Walmsley. They want Walmsley’s package to be sufficiently lower than the one awarded to her predecessor — Sir Andrew Witty — who is slated to retire later this month. His base salary is US$ 1.34 million (£1.1million) a year, while Walmsley’s proposed base salary is US$ 1.22 million (£1 million) a year, said news reports.

Some shareholders don’t think her proposed pay package fits Walmsley’s work experience. She is set to become Big Pharma’s first female CEO. But her resume is heavily tilted towards consumer products. Till recently, she was heading GSK’s consumer health joint venture. And prior to 2010 (a year when she joined GSK), she spent 17 years at cosmetics company — L’Oreal.

GSK is in “active consultations with shareholders” and is “acutely aware of the need for a balanced and responsible approach to remuneration,” a spokesperson said.

Children with AIDS write to India’s PM about Cipla’s Lopinavir

When the Indian government failed to clear its dues, Cipla — the only manufacturer of Lopinavir syrup (a child-friendly HIV drug) — stopped production of the drug. As a result, children living with HIV (CLHIV) have written to Prime Minister Narendra Modi for help.

The letter dated March 4 is signed by 637 children ranging from ages three to 19. “The pharmaceutical company Cipla has in various forums cited delay in payments by the national program for the HIV medicines by several years and even non-payment of its dues in many cases. Profits on child doses of HIV medicines are small and delayed payments are having a chilling effect on the ability of the National AIDS Control Organization (NACO) to convince the company to participate in the bids it invited annually,” the letter said.

Cipla is the dominant player in the Indian market across the HIV segment. Even though the Indian government has failed to pay Cipla for consignments it had sent back in 2014, the company has not stopped participating in government tenders.

The Health Ministry, on the other hand, says it has instructed State AIDS Control Societies (SACS) to purchase the drug from local markets. “An emergency tender has been placed but we have instructed SACS and state governments to purchase from local markets,” Arun Panda, Additional Secretary, Health Ministry, said.

Novartis faces drug ban in South Korea over bribe issue

Novartis is due to face additional punitive measures from the health ministry of South Korea later this month for allegedly providing illegal bribes to local doctors in exchange for prescribing its drugs.

Last week, the Korean Ministry of Health and Welfare said it is reviewing its own administrative actions against Novartis Korea, which could take the form of a fine or a lifting of insurance benefits on drugs sold by the company in South Korea. Novartis is headquartered in Basel, Switzerland.

Last week, the Korean Ministry of Food and Drug Safety had slapped Novartis Korea with a fine of US$ 174,937 (200 million won) and a three-month sales ban on 12 drugs, including variations of the company’s flagship dementia drug Exelon.

According to the ministry, this 200 million-won fine is equivalent to a three-month ban on 30 drugs, including Novartis’ top-selling diabetes drug — Galvus.

Korea’s punitive measures against Novartis Korea have come a year after Seoul prosecutors began a probe into a massive bribery scam that involved the company’s executives and employees.

In August last year, six former and current Novartis employees in South Korea were indicted over illegal practices to boost sales of the company's drugs.

Samsung Bioepis wins high-stakes case against AbbVie’s Humira

There is more news from South Korea. The Seoul-headquartered Samsung Bioepis, a biopharmaceutical company, won a high-stakes court case last week against US drug firm AbbVie for a biosimilar of the world's best-selling drug — Humira.

Samsung is keen to sell a version of this arthritis treatment in Europe sometime early next year. The biosimilar version of Humira is pending approval by the European Medicines Agency (EMA).

This ruling of the England and Wales High Court Chancery Division of the Patents Court, while determining that the two patents covering AbbVie’s Humira are invalid, also said that AbbVie's indications pertaining to rheumatoid arthritis, psoriasis and psoriatic arthritis were unpatentable.

The other claimant in this case is Tokyo-based Fujifilm Kyowa Biologics. In 2015, Humira displaced Pfizer’s anti-cholesterol drug Lipitor by crossing US$ 14 billion in sales.

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