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Penny Stock Fortunes -- January 2007 As these specialty drugs are developed, doctors across the globe will rely on these tests to tell them if the drugs will work for their patients. Including those with the most deadly diseases known to man. Help for a Worldwide Pandemic According to the World Health Organization (WHO), 38.6 million men, women and children are living with HIV/AIDS. AIDS has killed over 25 million people since it was first identified. And in developing countries, 6.8 million people need AIDS drugs. According to WHO, only 1.65 million of these patients receive the drugs they need to survive. It’s a growing problem. During 2005, HIV infected 4 million adults and children. This is why drug companies like Pfizer are working on better treatments. Pfizer just recently finished clinical trials of a new HIV drug designed to interfere with how the virus enters and infects human cells. Now that clinical trials are complete, Pfizer plans on announcing its results and submitting a New Drug Application to the FDA by the end of this year. But there is a catch. Doctors need to know the exact makeup of a patient’s HIV to determine whether this new treatment will work. And they can get these reliable tests from Monogram. Every Major Pharmaceutical Player in the World Needs This Tiny Biotech to Make Its Millions This past May, Pfizer and Monogram teamed up to make Monogram’s Trofile test available globally. The diagnostic was used to select patients for Pfizer’s trial of maraviroc — a new class of drug to treat HIV. Once the FDA approves maraviroc and Pfizer makes the drug available outside the United States, the company will market Monogram’s tests to physicians. These doctors will use the tests to determine whether the new treatments will help their patients. And with new treatments desperately needed in places like sub-Saharan Africa, it’s easy to see how a cutting-edge testing system could help save lives. Now that Pfizer’s clinical trials are winding down, Monogram is in a bit of a holding pattern. Revenue dipped this past quarter on what Monogram CEO Bill Young called a natural transition as the result of the completion of the clinical trials of maraviroc. This was by no means unexpected. Now Monogram is transitioning from primarily helping drug companies to making its tests available to doctors worldwide.
Now that enrollment is completed for the clinical trial, Pfizer expects to submit a New Drug Application for maraviroc to the FDA by the end of this year. This could be huge for Monogram. As these anti-HIV drugs become standard treatment, doctors around the world will need Monogram’s tests. And with 4 million new HIV patients diagnosed every year, there will be plenty of business for Monogram. And this isn’t the only drug giant Monogram is helping. In February 2006, Monogram’s tests were being used in a Phase 3 trial of a new HIV drug Merck is developing. This is the first Phase 3 trial for this new class of HIV drugs. More importantly, these clinical trials are by no means a one-time affair. The company and Pfizer have signed an agreement to involve Monogram’s tests in similar clinical programs through the end of 2009. And Monogram is establishing itself as a leader in its field by partnering with more than 60 organizations, including almost every single company with a significant HIV drug development program. On top of this, there are more than 60 of these new HIV drugs in development, some of which are considered to be the most advanced treatments ever tested. Why Monogram Could Become the Most Important Drug Company in the World In the U.S. market, Monogram is well placed with a sales and marketing force. The company also recently created a medical affairs group, as well as a commercial operations group. Company executives are making sure they are ready when the drugs are granted approval. The opportunities in the U.S. are important. Alone, the U.S. market for HIV drugs was $3.4 billion in 2005. But expanding globally is also important. This is why Monogram is working with Pfizer to expand international access to its tests. The catalysts in this situation should lead to big profits for Monogram. The eventual release of clinical trial results and the New Drug Application to be filed by Pfizer are huge for Monogram. Therefore, Pfizer’s interest in helping Monogram’s products to gain an international foothold is a no-brainer. When the new HIV drug is approved, doctors will need the proper tests in order to prescribe it to their patients. And Monogram’s tests will help physicians avoid treating patients who are unlikely to respond with this expensive drug therapy. |
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