Medgenics submitted an application seeking orphan drug designation for Infradure

Medgenics announced that it has submitted the application seeking orphan drug designation for the company's Infradure for the treatment of hepatitis D to the US FDA.

The company has recently submitted the Investigational New Drug Application to the FDA seeking initiation of the phase IIb trial evaluating the company's EPODURE for the treatment of anemia in dialysis patents.

Infradure utilizes the company's proprietary tissue-based Biopump which has designed to produce and deliver interferon-alpha using patient's own tissue. Epodure is designed in a similar concept but the drug in this case is erythropoietin.

The company is also currently developing HEMODURE which will produce and deliver clotting factor VIII for the treatment of hemophillia.

Watson to acquire Actavis

Watson announced that it is to acquire Actavis for a good EUR4.25B! Actavis is a privately held company that has presence in over 40 countries and have more than 1,000 products in the market. The company has been preparing to announce the news for awhile because accompanying the press release is a fancy video marketing the new acquisition. The video can be viewed on the company website (www.watson.com)

The companies hope to have the transaction closed by the fourth quarter of 2012. 

The acquisition will position Watson as a third largest generic makers in the world.   The company anticipates the combined revenue will be

Takeda received complete response letter from the FDA

Takeda said it has received a complete response letter from the FDA in regards to the company's New Drug Application submitted for the alogliptin and the fixed-dose combination of alogliptin and pioglitazone.

The company will immediately seek a meeting with the FDA to determine the next appropriate step.

Recently, the company has submitted postmarketing data related to the discussed medication to the FDA who has in addition requested more data.  Takeda is

Omontys is now available in the US

Takeda announced that Omontys is now available in the US.

In March 2012, Omontys (peginesatide) was approved by the FDA for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. This marks the entry of the only once-a-month erythropoiesis-stimulating agent for anemia available to dialysis patients in the US.  The product is to be co-marketed by Affymax and Takeda who will be responsible for the distribution of the product.

To order Omontys, providers can contact their group purchasing organizations, specialty distributors or call 1-855-Gomontys (1-855-466-6689)

Takeda prepares to announce the results of its 2011 fiscal year on May 11, 2012.

The FDA extends the review for Salix's Relistor

Salix and Progenics announced that the FDA has extended the review date for the company's supplemental new drug application for Relistor (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain.

The initial review date was April 27, 2012 but the date has been pushed back to July 27, 2012. The FDA cites that it need additional time to fully review the submission. Currently, no additional data or studies is required.

Methylnaltrexone is a peripherally acting mu-opioid receptor antagonist that works in the gastrointestinal tract with affecting the efficacy of pain relief from opioid.

The agent has been approved for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to other therapy (laxative) has not been sufficient

Amgen to acquire Mustafa Nevzat after an releasing an increase in sales in first quarter 2012

Amgen announced that it is to acquire Mustafa Nevzat, a privately held Turkish Pharmaceutical company for $700M. The all-cash transaction will put Amgen in a prominent position in Turkey and its surrounding region where Mustafa Nevzat has operation.

In 2011, the company had a revenue of $200M and has had double digit growth rate over the past year.

Amgen has recently reported the results of its first quarter of 2012 with a 9% increase in total revenues to $4.048B from 3.7B in the first quarter of 2011.

The company had a net income of 1.28B which is a slight increase from the same quarter of last year ($1.258B).

The company lead product sale was Neulasta which contributed to approximately 1B in sale in the first quarter of 2012 worldwide. Enbrel comes in second with the sale of approximately 938M in the first quarter in both the US and Canada market. In total, sales have increased approximately 300M in the first quarter of 2012 when compared to the first quarter of 2011 (3.9B vs 3.6B).

The German Federal Joint Committee confirms additional benefit of eribulin in the treatment of advanced metastatic breast cancer

Eisai announced that the German Federal Joint Committee has confirmed the additional benefit of using Halaven (eribulin) for the treatment of metastatic or locally advanced breast cancer when the medication was compared to other treatments. The assessment utilizes the results of the EMBRACE (Eisai Metatstatic Breast Cancer Study Assessing Treatment of Physician’s Choice vs Eribulin R7389) trial showed that a statistically significant increase in overal survival benefit was shown in patients with heavily treated advanced breast cancer compared to physician’s choice.


The phase III EMBRACE trial is an open-label, randomized, multicenter, paralell two-arm study evaluating erubilin against treatment of physician’s choice. The study aimed to compare the overall survival between the two arms. The results showed that patients taking erubilin survived an additional 2.7 months when compared to the other arms. The difference was statistically significant. The most common adverse reactions reported were asthenia, neutropenia, anemia, alopecia, peripheral neuropathy, nausa and constipation. The most comon serious side effects were neutropenia with or without fever.

Halaven is a non-taxane, microtubule dynamics inhibitor .

Takeda received positive opinion from the CMPH for ferumoxytol

Takeda and AMAG released a statement announcing the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency in regard to the companies’ ferumoxytol for the treatment of iron deficiency anemia in adult chronic kidney disease patients.


The positive opinion is issued after the committee reviewed data from three pivotal phase III trials evaluating ferumoxytol administered as a rapid injection. The majority of patients enrolled in the trial had chronic kidney disease (1562 out of 1726). The results showed that ferumoxytol significantly increase the hemoglobin levels (one of the measurements that is used to show the amount of red blood in the body) compared to oral iron supplement.

Ferumoxytol is an intravenous iron therapy that has been approved in Canada and the US. Ferumoxytol was developed by AMAG who entered into the comarketing agreement with Takeda in March 2010 allowing Takeda to market the product outside of the US.

Watson launches generic and faces lawsuit

Everyone knows that the market for diabetes medication is not going away. Watson has recently announced that it has launched an authorized generic version of Fortamet (metformin hydrochloride extended-release tablet) as part of the company’s agreement with Shionogi. Based in IMS health data, the sales of Fortamet and its generics reached approximately $82M.


On the same day, the company has also confirmed that Depomed and Valeant have filed a patent infringment lawsuit against Watson in regard to the company’s abbreviated new drug application submitted to the FDA seeking approval to market Glumetza (10000 mg metformin extended release tablet). The lawsuit intends to prevent Watson from marketing the product prior to the expiration of the US Patent nos 6,488,962 and 7,780,987. Because the lawsuit was filed under the provisions of the Hatch-Waxman Act, the ANDA submitted by Watson is not able to be granted approval for up to 30 months or until the resolutions have been resolved.



Based on the sales data generated by IMS Health, the US sales of Glumetza reached $80M in the 12 months ending Feb 28, 2012.