Recently, Mylan Inc.‘s (MYL) subsidiary, Matrix Laboratories received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) capsules in two dosage forms (15 mg and 30 mg). Mylan plans to begin shipment of the product immediately.  The drug is the generic version of Takeda Pharmaceuticals' (TKPHY.PK) proton pump inhibitor Prevacid DR Capsules. According to IMS Health (RX), the branded version had US sales of approximately $3 billion for the 12 months ending June 30.  Mylan received quite a few approvals in the recent past. In October, Mylan settled its dispute with Pfizer (PFE) related to the patent of antifungal drug Vfend (voriconazole), following which Mylan received the approval to launch the generic version of the drug. Additionally, in September, Mylan received FDA approval for its generic version of Bristol-Myers Squibb's (BMY) Sinemet ...

Mylan, Inc. (MYL) reported third quarter earnings per share of 32 cents, above both the Zacks Consensus Estimate of 27 cents and 23 cents in the prior-year period. The company reported revenues of $1.26 billion, a 24% decline from the year-ago period. However, the year-ago period included $455 million of revenue related to the sale of the product rights of Bystolic. Excluding this, total revenues increased 5.2% over the third quarter 2008. Revenues would have increased 9%, but for the unfavorable movement of foreign currency. From this quarter onwards, Mylan has decided to report its results in two segments -- Generics and Specialty -- following the acquisition of approximately 24% of the remaining interest in Matrix and the related de-listing. The former Matrix segment has been included in the Generics segment. The Generics Segment, accounting for about 88% of total revenues during the quarter, increased marginally ...

Recently, Mylan (MYL) announced the settlement of its dispute with Pfizer (PFE) related to the patent of antifungal drug Vfend (voriconazole). Now Mylan can launch an authorized generic version of the drug in two dosage forms of 50 mg and 200 mg tablets in early 2011. Mylan’s subsidiary, Matrix Laboratories, has Food and Drug Administration (FDA) approval for the generic version of the drug. Being the first company to submit an Abbreviated New Drug Application (ANDA), Matrix expects to be eligible to receive 180 days of marketing exclusivity for the drug. However, the agreement does not include liquid or intravenous versions of Vfend. The agreement has yet to be approved by the US Department of Justice and the Federal Trade Commission. Vfend recorded sales of $164 million in the 12 months ended June 30. Mylan received quite a few approvals in the past few ...

We are pleased to hear that Mylan (MYL) has begun to market the generic version of BenzaClin (1% Clindamycin and 5% Benzoyl Peroxide Gel) for acne treatment, which was originally manufactured by Sanofi-Aventis (SNY). The drug has been developed under an agreement between its subsidiary, Mylan Pharmaceuticals and Dow Pharmaceutical Sciences, a subsidiary of Valeant Pharmaceuticals International.

Earlier this month, Dow received the US Food and Drug Administration (FDA) approval for the generic drug. Although the approval is good news for the company, we do not expect it to contribute significantly to the top line since BenzaClin had total U.S. sales of about $221 million for the 12 months ending June 30 (as per IMS data).

This is the third approval for Mylan in the month of August. A few days back, Mylan’s subsidiary Matrix Laboratories received tentative approval from the FDA under the President's Emergency Plan for AIDS Relief

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A subsidiary of Mylan Inc. (MYL) recently received approval for marketing Sumatriptan Succinate Tablets from the US FDA. This generic version of GlaxoSmithKline's (GSK) Imitrex is meant for the treatment of migraine and headache. The drug had recorded total US sales of about $934 million in the 12 months ended June 30. But Mylan is a late entrant in this segment as Dr Reddy’s Laboratories (RDY) became the first to launch a generic version of the drug last November.

Mylan is now the third-largest generic company in the world after the acquisition of Merck Generics and Matrix Labs. We expect the Merck Generics acquisition to contribute significantly to Mylan’s long-term growth and the help the company expand its footprints in non-U.S. markets.

At present, the company has 120 abbreviated new drug applications (ANDAs) that are awaiting FDA approval, targeting approximately $85.6 billion in branded sales. Among

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Mylan Inc. (MYL) entered into a strategic partnership with Biocon Ltd to expand into the area of biotechnology. Biocon has a strong portfolio of biopharmaceutical drugs that include insulin, erythropoietin and monoclonal antibodies. The collaboration will help both companies to develop, manufacture and commercialize generic biotech medicines without duplicating associated costs. The deal mainly focuses on monoclonal antibodies used to treat diseases such as cancer and rheumatoid arthritis.

Mylan develops, manufactures, markets, licenses, and distributes generic, branded, and branded generic pharmaceutical products, as well as active pharmaceutical ingredients (APIs). In order to expand its product line, Mylan has been pretty active in forming strategic alliances with pharmaceutical companies to develop products or to launch distribution and licensing arrangements. After the acquisition of Merck Generics and Matrix Labs, Mylan is now the third-largest generic company in the world.

Mylan has a robust generic product pipeline and the total

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Mylan, Inc. (MYL) is engaged in the development, manufacture, marketing, licensing, and distribution of generic, branded, and branded generic pharmaceutical products, as well as active pharmaceutical ingredients (APIs). With the acquisition of Merck Generics and Matrix Labs, Mylan is now the third largest generic company in the world.We expect the Merck Generics acquisition to allow Mylan to expand its footprints in non-U.S. markets and to contribute significantly to long-term growth. Mylan also announced certain strategic initiatives which should help drive long-term growth. Besides this, Mylan has been working on improving its capital structure, which should help ease concerns regarding its liquidity position.The company's results over the past two quarters exceeded both ours and the Street's expectations. The strong performance should continue going into 2009. We maintain our Hold rating with a target price of $10.Arpita Dutt contributed to this report....

While we expect Mylan Inc.’s (MYL) acquisition of Merck Generics to contribute to long-term growth, near-term execution risks remain. Mylan announced certain strategic initiatives which should help drive long-term growth. We view these initiatives as steps in the right direction. But the management also stated that they expect 2008-2010 EPS to be negatively impacted by a slower-than-expected new product launch.

The company adjusted EPS guidance for 2008-2010 based on higher expenses, reduced opportunities from patent challenges and the potential sale of its specialty business. We believe that the new guidance should be achievable and we have updated our model based on the guidance. The company expects to conclude the sale of its specialty business later this year - we have removed contributions from this segment from the fourth quarter onwards. We maintain a Hold rating on the stock.

The Merck Generics acquisition will allow Mylan to expand its footprints in

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