This week, Phispers brings you news about Teva — which received a warning letter from the FDA for its China facility and a setback from the Mexican regulator in its ongoing legal battle with Rimsa. Also, there is news on how Aspen employees allegedly destroyed stocks of life-saving drugs, along with news on Eli Lilly, Korea’s Hanmi and Pfizer-BMS. Read on.
FDA issues warning letter to Teva’s China facility; Mexico regulator supports Rimsa
The warning letter came in on April 10, based on a regulatory inspection carried out in September last year. Teva said they are in the process of addressing the concerns raised by the FDA and will respond to the regulator by May 1.
The FDA referenced several deficiencies at Teva’s active pharmaceutical (API) plant pertaining to production controls and sampling techniques and processes.
To make matters worse for the Israeli drugmaker, Mexico’s pharmaceutical regulator — Federal Commission for the Protection against Sanitary Risk (COFEPRIS) — issued a memorandum that appears to undermine the claims of Teva against drugmaker Representaciones e Investigaciones Medicas SA, known as Rimsa, which it acquired for US $2.3 billion in 2015.
In the memorandum, COFEPRIS says it found no “unexpected adverse effects” in 147 drugs produced by Rimsa. It said the drugs were safe. Teva is engaged in a legal battle against Rimsa for allegedly selling defective products and duping regulators.
In September 2016, the former owners of Rimsa had filed a legal suit in a New York State court against Teva’s subsidiary Lemery SA, saying Teva was suffering from “a classic case of buyers’ remorse” and was therefore alleging that the former owners fraudulently induced it to purchase the Rimsa companies.
Teva has had issues with the FDA since last year. And these have affected its operations. The company has received two warning letters in just six months, say news reports.
Aspen’s staff plotted to destroy stocks of life-saving drugs
Employees at Africa’s leading drug company — Aspen Pharmacare — reportedly plotted to destroy stocks of life-saving medicines during a price dispute with the Spanish health service in 2014. In fact, leaked internal emails suggest that employees at Aspen called for a “celebration” over price hikes of cancer drugs, an investigation has revealed.
In October last year, Italian antitrust authorities fined Aspen nearly US $ 5.5 million for halting supplies of several cancer drugs. The authorities viewed this as a negotiating tactic to hike the prices of these cancer drugs by as much as 1,500 percent. The price-gouging episode began after Aspen purchased five different cancer drugs from GlaxoSmithKline. It then began negotiations with the Italian Medicines Agency over pricing for the cancer medicines.
This news from Aspen comes at a time when Baxter’s possible price fixing of intravenous (IV) saline has led to an employee being subpoenaed. Baxter said the subpoena, obtained by federal investigators, is “pursuant to a criminal investigation”. It calls for the employee to produce documents and testimony related to pricing, shortages of Baxter's IV solutions “and communications with competitors regarding the same,” the company said.
hope to slow generic competition to Eliquis through patent suits
Pfizer and Bristol-Myers Squibb have filed 16 patent infringement suits against generic drug makers over the last fortnight. And these include legal suits against companies like Mylan, Dr. Reddy’s Laboratories and Accord Healthcare.
With these patent infringement lawsuits, the two companies hope to slow the advance of generic versions of their shared blockbuster Eliquis.
Eliquis is a stroke and blood clot preventer that brought in about US $3.3 billion for BMS last year, up nearly 60 percent from the US $1.9 billion earned the year before. Pfizer, on the other hand, earned US $1.6 billion from this drug.
The two companies have gone to great lengths to protect and promote this drug — which is a top-selling product for both companies. Pfizer spent US $174 million on direct-to-consumer advertising for Eliquis last year.
Modi says India
may bring legal framework for doctors to prescribe generics
India is keen on encouraging cheaper generics over branded drugs. India’s Prime Minister Narendra Modi on Monday indicated that his government may bring in a legal framework under which doctors will have to prescribe generic medicines to their patients, which are cheaper than the corresponding branded drugs.
The government has brought in a health policy after 15 years and capped the prices of medicines and stents, which has angered some pharmaceutical companies, Modi said.
“Doctors write prescriptions in such a way that poor people do not understand the handwriting, and he has to buy that medicine from private stores at high prices,” Modi said.
“It is the government’s responsibility that everybody should get health services at minimal price,” he added.
Lilly to do more work on its new rheumatoid arthritis drug
The Indianapolis-based drug company and its partner Incyte were expecting an approval for baricitinib. Instead, they received a complete response (CRL) letter from the FDA, which said they need to do more work on the drug.
FDA wants to see additional clinical data to get the doses right and to better characterize safety concerns for the once-daily oral medication for moderate-to-severe rheumatoid arthritis (RA), Eli Lilly said.
More trials will increase the time and money that Eli Lilly and Incyte spend on baricitinib before its approval. Incyte and Lilly both said they are committed to working with the agency to get approval.
“We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA,” Christi Shaw, president of Lilly Bio-Medicines, said in a statement. “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the US,” Shaw added.
Controversy around Korea’s Hanmi and the death of a patient
Korean drug maker Hanmi is involved in a controversy pertaining to its cancer drug — olmutinib. A Korean patient taking this drug died from a rare case of Stevens-Johnson syndrome. And the death was reported after 14 months to the country’s health authorities. As a result, Hanmi’s partner — Boehringer Ingelheim — abruptly withdrew from their US $730 million partnership for olmutinib.
The death of the patient occurred in July 2015, when the patient was taking olmutinib and two other drugs. The physicians involved in the case said it was triggered by the other drugs and reported the case to a monitoring agency. But it was not reported as an unexpected serious adverse event. Hanmi and the agency finally reported the death to health officials in September, 2016.
According to Korean officials, Hanmi broke two medical laws related to monitoring and reporting clinical trials. The opposition party in Korea said the influential Hanmi had intentionally delayed reporting the death so it could get the drug approved in Korea. But investigators say they found no evidence of that.