Mylan's HIV Drug Gets Tentative FDA Approval

Yesterday 21 August 2009, Mylan Inc. (MYL) announced that its Indian subsidiary, Matrix Laboratories, received tentative approval from the US Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its generic version of a fixed-dose combination of Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate tablets in 600 mg/200mg/300 mg dosage strengths.

The decision is in response to an Abbreviated New Drug Application filed by the Indian subsidiary. The tentative approval under PEPFAR is indicative of the fact that the product satisfies all the manufacturing quality, safety and efficacy standards laid down by the agency.

The Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate combination is the generic version of Gilead Sciences’ (GILD) Atripla tablets used for the treatment of HIV-1 infection in adults. It combines three anti-AIDS medicines into a single, daily dose for either first- or second-line treatment and is one of the best-selling AIDS products in developed countries.

The combination of the three anti-AIDS drugs into a single daily dose is not only patient friendly but also cost effective. Existing patents prevent the marketing of the generic product in the U.S. However, the Atripla generic can be purchased in many developing countries outside the U.S.

This tentative nod by regulators strengthens the efforts of Mylan and Matrix to provide increased access to life-saving, affordable AIDS treatments in developing countries. It will also boost Matrix's wide range of ARV (antiretroviral) products. At least one Matrix ARV product is used to treat nearly 30% HIV/AIDS patients in developing countries.

Written by - Shah Anaym Kabir, Financial Analyst, LSE/NYSE/DSE/CSE.

Managing Director, EARTH MOVERS, email: s.anaym@yahoo.com; earthmvrs@gmail.com

Upcoming Ramadan & Investor's Thinking over DSE

It is called that during holly Ramadan DSE smashes all the money of small capital investors. By following tradition investors also are to ready to pass their whole day at home leaving securities farms. The scenario is likely the waste land of T.S Eliot; there is none in a place.
But now a day investors keeping digital idea in mind started to think reversely. New investors are being exposed to DSE/CSE is not unknown to all. As a result volume is going to momentous form gradually that is found in technical DSE chart. All the indicators are positive and showing much strength indicating near future advance movement. Technically the chart shows throughout this month price will be moving and will reach to previous resistance at 3100 levels. So, it is clear that DSE will not decline in the holly month this year anymore; rather breaking all previous tradition it will be advanced to the half of the Ramadan.
On the other hand, ‘Z’ categories companies will be matured after 10 days of buying, according to Regulatory Body. The intention is to make the investors more followers of ‘A’ categories companies. According to many this is a good idea to keep the stock stable and protect gambling by so-called syndicates.
The writer upgraded Bextex as BUY and rated to the price limit tk.100, without it he upgraded Beximco ltd, Daffodil, Intech, BD Online, BD Com, Agni System, BD Thai. He expressed his deepest sock at ‘B’ and ‘N’ categories companies. He suggested the investors to avoid all kinds of ‘Z’ categories companies at least before Eid-ul Fithor.

Written be – Shah Anaym Kabir, Financial Stock Analyst, DSE/CSE/LSE/NYSE

Managing Director, Earth Movers, e-mail: earthmvrs@gmail.com ; s.anaym@yahoo.com