Mylan quality control issue with FDA not necessarily over (MYL)
The FDA might not be done looking at reported quality control problems at Mylan Inc. (NYSE: MYL) after all.
Mylan came out Tuesday morning and said FDA investigators found no serious quality control violations at its Morgantown, West Virginia generic drug facility. But the FDA came out this afternoon denying the company’s statement.
“The investigation is ongoing and the agency has formed no conclusions at this time; Statements to the contrary are untrue,” the company told the Associated Press in a story that appeared at roughly 12:30 Eastern.
It remains to be seen if how deeply the FDA may look into reported quality issues at Mylan, the No. 3 U.S. drugmaker, and for how long.
The agency has taken a hard look in recent months at other generic manufacturers including India’s Ranbaxy Laboratories, in an investigation that helped that company’s stock price far lower. The FDA began putting pressure on Ranbaxy in September 2008, warning that it failed to meet U.S. manufacturing standards for 30 generic drugs at two of its plants. In February, the FDA accused the Ranbaxy of falsifying data and test results in approved and pending drug applications.
Mylan early today said in a statement that the FDA found only minor infractions of standard procedures at the plant, following an expose in the Pittsburgh Post Gazette on Sunday that appears to have launched the probe.
The Post Gazette story highlighted an internal report obtained by the newspaper that said workers were routinely overriding computer-generated warnings about potential problems with the medications produced at the plant, in violation of federal quality control procedures. The Post-Gazette cited an internal report that said the company found serious violations, involving falsifying information and altering product. The Post Gazette said the company report noted the practice was “pervasive.”
Mylan reportedly contacted the FDA over the weekend to notify the agency about the Post Gazette article, and the FDA visited the Morgantown facility on Monday.
While Mylan says that the plant visit resulted in the FDA finding only a minor deviation in standard operating procedures, the FDA is not backing up that company statement.
The truth could be somewhere in the middle: Perhaps an off-the-cuff remark by an inspector gave Mylan executives the impression that the FDA would not launch a major probe.
But based on the FDA’s apparent retort following Mylan’s statement, it appears that potentially miffed FDA inspectors are not through looking around — Mike Tarsala.
Generics and Cancer, Prostate Cancer (MYL, AZN)
Mylan Inc. (NASDAQ: MYL) has announced an unusual generic drug approval this morning. The company’s subsidiary Mylan Pharmaceuticals received approval from the FDA for its Abbreviated New Drug Application for Bicalutamide Tablets, 50 mg. It would seem that there is a chance that this could be a game changer if everything works fine and if the treatment of cancers can be moved to generics rather than name brands drug and biologics.
Bicalutamide tablets are the generic version of the AstraZeneca (NYSE: AZN) prostate cancer treatment called Casodex(R). This is not the largest drug out there, but it had total U.S. sales listed as being approximately $322 million for the 12 months ending March 31 for the same strength, according to IMS Health. Mylan has begun to ship this product.
There is just one question left, and this is not an easy sell. If you have prostate cancer, are you going to just say “OK” when your doctor says that there is now a cheaper generic that is believed to do the same thing? While that is a personal dilemma, there is always the notion that many patients won’t have a choice.
Jon C. Ogg
July 7, 2009
Generics vs. Brands: Is Mylan Takeover Bait? (MYL, PFE)
Mylan, Inc. (NYSE: MYL) is trading up today on some hope that an analyst research report that puts the company down as possible takeover bait. The report comes from Caris & Co., and the possible interested buyer is said to be Pfizer Inc. (NYSE: PFE). This may sound odd, but Pfizer has made actions toward generic growth expressed how there is more and more interest in generic drugs.
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Big Pharma vs. Indian Generics, The Plot Thickens (PFE, TEVA, MYL)
Pfizer Inc. (NYSE: PFE) is sort of stuck between a rock and a hard place. If you thought that Big Pharma drug companies being under fire because of generic drugs, the issues may about to be getting much more convoluted. There are reports that Pfizer may try to make an acquisition offer for a majority stake in the Indian generic giant Ranbaxy. This would be a counter-bid or counter-fight since Japanese drug maker Daiichi Sankyo’s recent plan to spend up to $4.6 Billion to acquire a majority stake in Ranbaxy.
What is interesting is that Ranbaxy is India’s biggest drug maker. To make matter more complicated, Ranbaxy has been involved in many cases globally over launching generic versions before Pfizer’s patents expire on Lipitor as a cholesterol treatment. Ranbaxy may launch a generic version of Pfizer’s Lipitor as soon as 2010, although this will vary greatly depending on which country it pertains to.
The fighting between generic drug makers and name brand makers is an endless one. Teva Pharmaceutical industries (NASDAQ: TEVA) recently saw a huge hit to its stock because of a generic MS drug out of Mylan Labs (NYSE: MYL) of Teva’s blockbuster Copaxone. Guess where the generic is going to be made….. Mylan teamed with NATCO Pharma, out of India. The irony here is that Teva’s lion share of revenues come from generic drugs that it makes of other Big Pharma labels. The sword cuts both ways.
The wars with generics and Big Pharma makers are only going to get worse and are only going to get more complicated. Throw in the biotech angle and the recent moves where Big Pharma companies have been acquiring biotechs for their prized pipelines. Stay tuned.
Jon Ogg
June 13, 2008
Top Med-Bio Analyst Calls (ARAY, ABI, MYL, PDLI)
It’s actually a fairly light morning in analyst calls, particularly in medical and biotech shares. Here are four of the calls that we have seen so far this morning:
- Accuray (NASDAQ: ARAY) Cut to Sell from Neutral at UBS.
- Applied Biosystems (NYSE: ABI) Cut to Neutral from Buy at UBS.
- Mylan Labs (NYSE: MYL) started as Buy at Caris.
- PDL Biopharma (NASDAQ: PDLI) Cut to Neutral from Outperform at Credit Suisse.
Jon Ogg
June 13, 2008
Top Med-Bio Analyst Calls (ARAY, ABI, MYL, PDLI)
It’s actually a fairly light morning in analyst calls, particularly in medical and biotech shares. Here are four of the calls that we have seen so far this morning:
- Accuray (NASDAQ: ARAY) Cut to Sell from Neutral at UBS.
- Applied Biosystems (NYSE: ABI) Cut to Neutral from Buy at UBS.
- Mylan Labs (NYSE: MYL) started as Buy at Caris.
- PDL Biopharma (NASDAQ: PDLI) Cut to Neutral from Outperform at Credit Suisse.
Jon Ogg
June 13, 2008
Teva's Copaxone MS Franchise Under Generic Fire (TEVA, MYL)
Shares of Teva Pharmaceuticals (NASDAQ: TEVA) are under fire this morning, in a move which has more irony than one might guess. Mylan inc. (NYSE: MYL) has signed a licensing pact with India’s NATCO Pharma Ltd. to produce a generic version of Teva’s multiple sclerosis treatment called Copaxone.
This involves access to NATCO’s pre-filled syringes of glatiramer acetate, the generic name for Copaxone. Mylan gains exclusive distribution rights as part of the deal in the United States, major markets in Europe, Japan and elsewhere. NATCO already has commercialized its glatiramer acetate product in India and Ukraine.
Copaxone generated about $1.7 Billion in sales for Teva last year, and the company’s totsal currency-converted revenues were about $9.4 Billion. If you have followed Teva for some time you might appreciate the irony in this if you are not a shareholder. Guess were Teva’s largest revenues come from… generic drugs.
Teva closed at $44.76 yesterday and shares are down over $1.00 in pre-market trading on almost 500,000 shares with about 35 minutes to the open.
Jon Ogg
June 10, 2008
