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Teva entered the FDA’s shame list

FDA’s shame list includes 40 pharmaceutical manufacturers such as Novartis, Bayer and Pfizer, which “game the system” to block generic drug competition


The Food and Drug Administration (FDA) published the list of shame, which includes 40 pharmaceutical manufacturers trying to block generic drug competition. Among the companies are giants such as Novartis, Maylan, Bayer and Pfizer, as well as the largest Israeli pharmaceutical company Teva.

The drug for which Teva is named is subject to an FDA-imposed Risk Evaluation and Mitigation Strategy limiting its distribution so that it is likely to receive the benefit of the doubt over the reason that it took four inquiries with the FDA before Teva’s competitors managed to obtain samples of the drug.

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The list includes companies about which the FDA has received complaints that they prevented generic drug companies from obtaining samples of their brand drugs so that the generics companies could copy them legally.

According to the FDA the generic companies generally, need between 1,500 and 5,000 units of the brand drug in order to carry out tests demonstrating that their generic version is bioequivalent to it. Teva’s name appears among those which used this blocking delaying tactic in relation to more than one drug.

The price of generic drugs in the United States has not led to a severe public mood and harsh statements against the profits of the pharmaceutical companies at the expense of the country’s citizens.

In addition, Teva was informed this weekend that the FDA had authorized Amgen to market its Aimovig injection for migraine. On the other hand, Teva’s product (Fremanezumab) for prophylactic treatment of migraine was recently rejected.

According to The Wall Street Journal, Amgen’s treatment will be available within a week. The targeted injection should be taken once a month, and the treatment is expected to reach an annual cost of $6,900 per patient, a relatively cheap price. Amgen has already announced that it expects the drug to be its next blockbuster. Investors were not moved by the news, and Teva rose 0.5% on Friday.

The opening of the competition by Amgen caught Teva in an uncomfortable position after it recently announced that the FDA would not grant marketing authorization to Fremanezumab until at least next month.

The reason for the delay is related to the manufacturer of the drug, Celerion, who received a warning letter after an inspection at the plant. Teva expects the approval to be made by the end of the year, although some analysts disagree. Migraine is an unpredictable neurological condition, accompanied by severe, physically debilitating headaches that can impair quality of life and function. It is expressed in two clinical ways: Chronic migraine, in which patients suffer from headaches for 15 days or more a month; And a chronic migraine, which is characteristic of 90% of patients who suffer from headaches up to 14 days a month.

According to Teva, more than a billion people suffer from migraine, making it the third most common disease in the world and the sixth most restrictive disease in the world.

In the United States, Japan and the five major European countries, which are the company’s main markets, about 75 million people suffer from migraine headaches, more than 38 million of them in the US alone.

Of the 40% of people with migraine who have prophylaxis, only 13% are currently receiving treatment. According to recent analyzes, the economic burden of migraine on patients reaches $ 78 billion a year in the US alone.

According to the average of forecasts by analysts pricing Teva’s new drug, the annual revenues from Teva in both labels are expected to reach $ 985 million in 2022 and reach $ 1.7 billion in 2025. The analysts also note Teva’s advantage over its competitors – Amgen, Eldar and Eli Lilly. Unlike their drugs, which are administered once a month, Teva’s treatment is given once a quarter.

As mentioned above, giving precedence to Amgen’s injection for treatment of migraine headaches takes Teva at a bad timing.

The drug for migraine along with osteodenics for the treatment of late dyskinesia should have covered at least some of the damage caused by the opening of the generic competition for its flagship drug, Copaxone, for the treatment of multiple sclerosis.
The Augusto, which was approved by the FDA last August, posted only $ 30 million in the quarter.

Teva wanted to launch the drug for migraine first because it is a market that has experienced very little therapeutic innovation in 25 years, and the ability to capture market share with penetration is important.

Teva also purchased a voucher to prioritize $ 150 million to expedite the examination process.

Now the company is in a race against the clock to approve the injection before the end of 2018, so that she can enter the insurance basket of insurance companies in the US in 2019.





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