Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘Market Opportunity’

As reported today by BBC News,  a NJ based specialist pharmaceutical company, Antares Pharma has developed a gel based contraceptive, Nesterone® that is as effective as taking a pill, acccording to phase 2 clinical trial data presented at the annual meeting of the American Society of Reproductive Medicine (ASRM) in Denver.

According to researchers, the contraceptive delivered by the gel is as effective as that delivered by a traditional pill, but doesn’t show many of the adverse events and side effects such as weight gain & acne.  As always with promising phase 2 data, there is no guarantee that the phase 3 trial will show the same results, but this is definitely an innovative product to watch.

Nesterone® is being jointly developed with the Population Council (a non-profit organization). According to the lastest Antares Pharma investor presentation, they are looking for partnership opportunities for this product.  Based on the positive phase 2 data and a market worth $1B,  I am sure they will now have some business development interest.

Also, the company has a number of other injectable and transdermal gel products in development and collaborations with Teva, Uman Pharma and BioSante Pharmaceuticals. It will be interesting to watch how this small, emerging company and its products develop. A company to watch.

The news, reported by Bloomberg, last week that generic companies may be subject to stricter FDA standards in order to show therapeutic equivalence is good news for the biotech industry and consumers.

Generic companies have a pretty easy ride in obtaining product approval, and I’ve long been convinced that the formulation of a brand, and what makes it work can include the so called inactive ingredients and how it is put together.   I know of many people who have experienced side effects with generics that they don’t have with the branded product.

For this reason, branded generics from the original manufacturer have the ability to retain some market share in the face of generic competition.  Sandoz, the generic arm of Novartis uses this strategy to good effect with many mature products.   However, if companies instead want to try and maintain a premium priced brand and not adapt to the entry of generics, then they will find their market share erodes extremely fast. Not only is brand market erosion fast with generic drugs, but with biosimilars too.

As reported by Reuters, sales of generic enoxaparin sodium injection, Momenta’s copy of Sanofi’s anti-thrombotic, low molecular weight, heparin sold as “Lovenox” were $292million in the third quarter of 2010. Sandoz markets enoxaparin on behalf of Momenta. They launched the product on July 23, and achieved  $292 million of sales in 69 days. With annual sales forecast to be over $1billion, the biosimilar will be a blockbuster and make a significant dent in the $2.9 billion sales of Lovenox in 2009.

The Boston Business Journal reports that Sandoz/Momenta have captured 60% market share already, which is not good news for Sanofi-Aventis and may explain their desire to make acquisitions such as Genzyme to make up for this loss.

Biosimilars that are fully substitutable for the original product, look likely to erode brands extremely fast.  Momenta’s success is good for the biotechnology industry and highlights the future market opportunity from development of biosimilars.

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