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Pomalyst Receives FDA Nod For Multiple Myeloma

February 8, 2013

On February 8, 2013, the FDA approves of Celgene’s orphan drug Pomalyst (Pomalidomide) for patients with Multiple Myeloma (MM) whose disease progressed after being treated with other cancer drugs. This approval is received ahead of the PDUFA date of February 10. Pomalyst is a pill that is meant for MM patients who have received at least 2 prior therapies, whose MM didn’t respond to these treatments, and the MM has progressed within 60 days of last treatment – Relapsed and Refractory MM. According to a BioWorld.com article, Celgene spokesman Greg Geissman says Celgene expects to launch Pomalyst  in about two weeks.

This is the second drug approved for MM in the past year – Kyprolis (Carfilzomib) receives FDA approval for MM in July 2012. Both new drugs for MM receives FDA approval under the Accelerated Approval program. This program gives patients early access to new drugs while the company does additional studies to confirm the drug’s benefit and safe use. Pomalyst is the first new immunomodulatory drug since 2006 and approval is anticipated in Europe later this year.

Pomalyst is to be available in the United States only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program, which requires prescribers to be certified with the REMS Program.

Celgene currently has a strong presence in the MM market. Pomalyst will be extending the company’s leadership position in MM. Pomalyst belongs to the same class of drugs, immunomodulatory agents, as Revlimid (Lenalidomide) and Thalomid (Thalidomide), which are 2 orphan drugs that Celgene already markets as MM treatments in the US and internationally.

The International Myeloma Foundation (IMF) publishes a Press Release saying that the Pomalyst FDA approval will provide an important new option for patients who have not had positive outcomes with other cancer treatments.

Regulatory Timeline For Pomalyst

1) January 15, 2003Receives FDA Orphan Drug Designation (ODD) for MM

2) October 8, 2009Receives EMA orphan designation for MM

3) May 2012 – A Marketing Authorization Application (MAA) is filed with EMA

4) October 2012The November 8, 2012 FDA Oncologic Drugs Advisory Committee (AdComm) Meeting for Pomalyst is cancelled

5)  February 8, 2013 – FDA approves Pomalyst for RRMM ahead of PDUFA date.

Upcoming 2013 Key Catalysts for Pomalyst

1) H1:13 – Phase III RESUME (MF-002) data in Myelofibrosis

2) H2:13 – EU CHMP decision on RRMM

3) H2:13 – Submit sNDA for Myelofibrosis.

Multiple Myeloma Market

1)  Takeda’s orphan drug, proteasome inhibitor Velcade (Bortezomid) is the market leader, with > 60% share in 1st-line therapy & > 50% as a 2nd-line therapy

2)  Celgene’s orphan drug Revlimid is market leader with > 50% market share in front-line use

3)  Onyx Pharmaceuticals’ orphan drug, proteasome inhibitor Kyprolis (Carfilzomib) for Multiple Myeloma receives FDA approval in July 2012.

Pomalyst Indication For Myelofibrosis

Pomalyst may be the start of a new Celgene franchise. Pomalyst is in Phase III clinical trials for Myelofibrosis and may provide significant revenue in the future for this indication. Phase III RESUME (MF-002) study data for Pomalyst verses placebo in patients with Myelofibrosis is expected in 1H13, followed by an NDA filing later in the year. Also, it is important to keep in mind that the only approved treatment option for Myelofibrosis is Jakafi (Ruxolitinib) from Incyte, which only treats the enlarged spleen symptoms and has no effect on anemia.

Upcoming Celgene Calendar

1)  Celgene’s Chairman & CEO, Robert Hugin, Webcast at BIO CEO & Investor Conference, Monday, February 11, 2013 at 8:00 AM ET

2)  Celgene at Citi Global Healthcare Conference, Tuesday, February 26, 2013 at 9:35 AM ET

3)  Celgene at RBC Capital Markets’ Healthcare Conference, Wednesday, February 27, 2013 at 3:00 PM ET.

References

Celgene February 8, 2013 Press Release

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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