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PROHOST NEWS AND COMMENTS

CELLDEX: CROSSINGTHE BORDER TOWARDS A HIGHER STATUS

  Tuesday, March 17, 2015

As you would observe when reading the most recent Prohost Letters, our recent enthusiasm for Celldex Therapeutics (CLDX) emanated from its products' combinationsc with novel immunotherapy drugs. In the past months and yesterday and today CLDX has outperformed for the same reason we mentioned in our most recent Prohost Letters. The reason for the current outperformance was the announcement that Celldex  entered into a clinical trial collaboration with Roche to evaluate the safety, tolerability and preliminary efficacy of varlilumab investigational antibody, and MPDL3280A (anti-PDL1), Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma. More...

EXELIXIS: ON THE ROAD TOWARDS ACCOMPLISHMENTS WITH FASTER STEPS

  Thursday, February 19, 2015
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Exelixis Announces Acceptance of New Drug Application for Cobimetinib (NDA) in Combination with Vemurafenib for Treatment of Patients with BRAF V600 Mutation-Positive Advanced Melanoma

The FDA Granted Priority Review, Assigns Action Date of August 11, 2015” This is a subtitle in the firm’s news today, which says a lot about Exelixis (EXEL) as an active biotech firm. 

Exelixis has, indeed, designed, produced and developed a rich pipeline of small molecule cancer targeted products. The firm might have experienced a setback in one of its drugs in an indication other than this drug has been approved for. The result was a selloff that ate the firm’s scientific value, the values of its pipeline products, patented technologies and drugs and of the alliances who rushed to sublicense, develop and market exelixis licensed drugs.   

In today’s news, the FDA has accepted for review Genentech’s (Exelixis partner on the drug) New Drug Application (NDA) for cobimetinib in combination with vemurafenib for patients with unresectable or metastatic melanoma harboring a BRAF V600 mutation.

Cobimetinib is a specific MEK inhibitor. It was discovered by Exelixis and is now the subject of a worldwide co-development agreement between Exelixis and Genentech, a member of the Roche Group.

The FDA Granted Priority Review to the NDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 11, 2015. This means that the FDA determined that the combination treatment has the potential to provide significant improvements in the treatment, of advanced melanoma with positive BRAF V600 mutation. This form of melanoma needs new approaches for a more effective treatments. 

The NDA is based on data from coBRIM, a phase 3 pivotal trial conducted by Genentech. Roche also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for the combination of cobimetinib and vemurafenib in 2014.

To learn about the coBRIM Study in the firm’s press release Click HERE

Results: Regarding the results of this trial as presented during the Presidential Symposium at the European Society for Medical Oncology 2014 Congress, coBRIM met its primary endpoint, demonstrating statistically significant increase in investigator-determined progression-free survival (PFS).

The median PFS was 9.9 months for the combination of cobimetinib and vemurafenib versus 6.2 months for vemurafenib alone (hazard ratio [HR] = 0.51, 95 percent CI 0.39-0.68; p < 0.0001).

The safety profile of the combination was consistent with that observed in a previous study of the combination. The most common Grade 3 or higher adverse events in the combination arm included liver laboratory abnormalities, elevated creatine phosphokinase and diarrhea. The most common adverse events seen in the combination arm included diarrhea, nausea, rash, photosensitivity and laboratory value abnormalities.

The Exelixis/Genentech Collaboration

Exelixis discovered cobimetinib internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a worldwide co-development agreement with Genentech, under which Exelixis received initial upfront and milestone payments in connection with signing the agreement and submitting the IND.

Exelixis was responsible for development of cobimetinib through the determination of the maximum tolerated dose in phase 1, at which point Genentech exercised its option to further develop the compound.

In November 2013, Exelixis exercised its option to co-promote cobimetinib, if approved, in the United States. Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share equally in the U.S. marketing and commercialization costs. Exelixis is eligible to receive royalties on any sales of the product outside the United States.

Cobimetinib/ Vemurafenib Combination

Cobimetinib: A selective inhibitor that blocks the activity of MEK, a protein kinase that is part of a key pathway (the RAS-RAF-MEK-ERK pathway) that promotes cell division and survival. This pathway is frequently activated in human cancers including melanoma, where mutation of one of its components (BRAF) causes abnormal activation in about 50% of tumors. Tumors with BRAF mutations may develop resistance and subsequently progress after treatment with a BRAF inhibitor.

Vemurafenib: marketed as Zelboraf, the drug is a B-Raf enzyme inhibitor developed by Plexxicon, which has become part of Daiichi-Sankyo) and Genentech. The drug is indicated for the treatment of late-stage melanoma.  

In preclinical melanoma models, co-treatment with vemurafenib and the MEK inhibitor cobimetinib may delay the emergence of resistant tumors.

Prohost Comments

We believe this news is excellent, marking the beginning of Excelixis pipeline products march with faster steps towards approval and marketing of further products. The approval of the combination will also open the door for Exelixis to design and develop improved targeted drugs for cancers, as knowledge is improving about cancer pathways, cancer mutations and tumors’ resistance to treatments.

For Other Cancers Too: It is important to note that cobimetinib is also being tested in combination with several investigational medicines, including an immunotherapy in several tumor types, including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer and melanoma.

We love the news and the agreement about sharing every aspect of the drug’s marketing in the U.S. and about the royalties in other countries

With all what happened against this firm and the interest of its shareholders, we did not remove Exelixis from our portfolio of picked biotech stocks since we picked it.

AERIE PHARMACEUTICS IS SPEEDING TOWARDS IMPROVING THE MANAGEMENT OF GLAUCOMA

  Wednesday, February 11, 2015

AERIE PHARMACEUTICALS (AERI) More...

IRRATIONAL SELLOFF ADDING MORE IRRATIONAL VOLATILITY

  Wednesday, February 04, 2015

 More...

HAS THE TIME COME TO APPRECIATE AGENUS?

  Friday, January 09, 2015

Incyte and Agenus Announce Global Alliance to Develop  More...

A Huge step Forward In the Treatment Of Huntington Chorea

  Wednesday, December 17, 2014

A Drug, SD-809, Developed By Auspex Pharmaceuticals Could Be A Huge Step Forward In the Treatment Of Chorea Associated WithHuntington’s Disease, Called First-HD More...

ABOUT EXELIXIS

  Tuesday, December 02, 2014

ANSWERING YOUR QUESTIONS More...

A GIANT TECHNOLOGY ON THE MOVE

  Friday, October 24, 2014

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GILEAD: HARVONI WILL BE THE BLOCKBUSTER WE EXPECT

  Monday, October 13, 2014

A lot of talk, writings and insinuations were, and still are filling the media prior to, and following the FDA granting Gilead (GILD) approval for its all-oral HCV combination pill Harvoni. All that has been mentioned to date is questionable, except the fact that people infected with genotype 1a and 1b hepatitis C virus will no more suffer the side effects of the old oral drug ribovirin and injectable drug pegylated interferon alpha and, more important, the dreadful complications of hepatitis C viral infection.       More...

TOKAI A NEW COMMER TO THE BIOTECHNOLOGY MARKET

  Thursday, September 18, 2014

TOKAI (TKAI) More...

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