Biotech Weekly Commentary (June 4 – June 8)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of June 4– June 8, 2012

Biotechnology indices finished higher  with major US averages. Clinical updates at ASCO were in sector focus. For the week, the BTK advanced 2.44% to 1415.85, and the NBI rose 3.43% to 1283.53.

 

REGULATORY

Merck announced the FDA issued a CRL regarding the NDA for ridaforolimus in metastatic soft tissue or bone sarcoma. Merck rose 1.07% to $37.90 on Wednesday. Ariad Pharmaceuticals, which is partnered with Merck on ridaforolimus, gained 2.78% to $16.65.

GlaxoSmithKline and XenoPort announced the FDA approved Horizant ER Tablets in postherpetic neuralgia (PHN) in adults. Glaxo slipped 0.25% to $44.27 on Thursday, and XenoPort dropped 9.56%.

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Biotech Weekly Commentary (May 28 – June 1)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of May 28– June 1, 2012

Declines in biotechnology indices exceeded those in major US averages. For the week, the BTK receded 5.85% to 1382.11, and the NBI fell 4.53% to 1240.98. Each finished at the lowest levels since mid-April.

 

REGULATORY

Janssen Therapeutics, a division of Janssen Products, announced the FDA issued a CRL for a sNDA for an 800mg tablet of PREZISTA. PREZISTA is approved for once-daily oral administration of 800mg — two 400mg tablets — for the treatment of HIV-1 in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations.

Exelixis announced on Wednesday it completed the filing of its rolling NDA with the FDA for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer. Exelixis slipped 0.65% to $4.59.

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Biotech Weekly Commentary (May 21 – May 25)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of May 21– May 25, 2012

Biotechnology gains outpaced those in major US averages. For the week, the BTK rose 3.32% to 1467.97, and the NBI advanced 3.91% to 1299.90.

 

REGULATORY

Merck announced the FDA approved a labeling update for ISENTRESS (raltegravir) Film-coated Tablets to include 156-week data from the STARTMRK study with ISENTRESS in combination therapy compared to efavirenz in combination therapy in previously untreated (treatment-naïve) adult HIV-1-infected patients. Merck fell 0.58% to $37.60 on Monday.

Vertex Pharmaceuticals announced on Friday the CHMP issued a positive opinion by consensus recommending the approval of KALYDECO for people with CF ages 6 and older who have at least one copy of the G551D mutation in the CF transmembrane conductance regulator gene. Vertex rose 1.19% to $64.85.

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Biotech Weekly Commentary (May 14 – May 18)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of May 14– May 18, 2012

Biotechnology underperformed major U.S. averages. Investor de-risking on macro-economic uncertainty sharply impacted the sector late in the week. Meanwhile ASCO abstracts and the Bank of America Merrill Lynch Healthcare Conference received attention. For the week, the BTK fell 6.03% to 1420.72, and the NBI declined 4.75% to 1251.04.

 

REGULATORY

OraSure Technologies announced the FDA Blood Products Advisory Committee provided a unanimous positive recommendation for the company’s OraQuick In-Home HIV Test. OraSure rallied 20.33% to $10.95 on Wednesday.

Achillion Pharmaceuticals announced the receipt of a Fast Track designation from the FDA for ACH-3102 as part of an interferon-free regimen for the treatment of chronic HCV. Achillion fell 1.02% to $6.82 on Tuesday.

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Extel IR Best Practices Americas Survey – win an iPad! Extended to July 1st

The Thomson Reuters Extel 2012 Investor Relations North America study has begun!

I invite you and your IR team to take part in the first Thomson Reuters Extel Investor Relations study for North America.

Voting runs until July 1st, 2012.

To take part –

Online at www.extelsurveys.com (Log in with your email address & your password; then click on the VOTE NOW button or

By email: please request an interactive PDF questionnaire which you can return to us by email or fax

Why take the survey?

Every company taking part will get a complimentary copy of the Executive Summary report, giving you the highlights on the key trends in IR, and what the buy-side and sell-side are really looking for from IR teams.

And one lucky winner will win a new Apple iPad!

I do hope you will be able to take part in the Survey, and please let me know at any time if you have questions or concerns.

Thank you and regards,

The Extel Team

extelsurveys@thomsonreuters.com

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Biotech Weekly Commentary (May 7 – May 11)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of May 7– May 11, 2012

Sector gains outpaced those in major US averages. A series of positive regulatory rulings and clinical read-outs provided industry-specific strength. Mid-cap company earnings, several of which provided visibility into drug launch progress, were mixed. For the week, the BTK climbed 4.14% to 1511.91, and the NBI rose 3.83% to 1313.48.

 

REGULATORY

Pfizer announced on Wednesday the Arthritis Advisory Committee to the FDA voted 8-2 to recommend approval of tofacitinib in adult patients with moderately to severely active RA. The FDA has provided an anticipated PDUFA action date in August 2012. Pfizer rose 1.13% at $22.45.

Reuters reported an experimental obesity pill from Arena Pharmaceuticals won a U.S. panel’s support. A panel of outside experts to the FDA voted 18 to 2, with one abstention, to recommend approval of lorcaserin. The FDA will make a final decision by June 27. Arena soared 73.77% to $6.36 on Friday.

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Extel IR Best Practices Survey – win an iPad!

The Thomson Reuters Extel 2012 Investor Relations North America study has begun!

I invite you and your IR team to take part in the first Thomson Reuters Extel Investor Relations study for North America.

Voting runs from April 30th to May 25th, 2012.

To take part –

Online at www.extelsurveys.com (Log in with your email address & your password; then click on the VOTE NOW button or

By email: please request interactive PDF questionnaire which you can return to us by email or fax

Why take the survey?

Every company taking part will get a complimentary copy of the Executive Summary report, giving you the highlights on the key trends in IR, and what the buy-side and sell-side are really looking for from IR teams.

One lucky winner will win an iPad!

I do hope you will be able to take part in the Survey, and please let me know at any time if you have questions or concerns.

Thank you and regards,

 

Extel team

 

 Contact details:

 

extelsurveys@thomsonreuters.com

 

Tel. +44 (0) 20 7542 7700

 

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Case Study: Benefits of Self-Publishing Regulatory Releases

Corporate communications professionals are publishing their own content every day: tweets, blog posts, email announcements, website copy, Facebook posts (to name just a few). Yet most still rely on a third party wire service to review and publish their regulatory and press releases—and they’re paying for it. Many are looking for an alternative to this time consuming and often costly process.

Constellation Brands—the world’s leading premium wine producer—has implemented such an alternative using a secure self-publishing tool from Thomson Reuters. They now have full control of their releases from start to finish and are reallocating the cost-savings toward other activities such as measurement.

“The Thomson Reuters release publishing solution helps us meet our SEC disclosure requirements through a secure process,” said Patty Yahn-Urlau, Vice President of  Investor Relations at Constellation Brands. 

Read the case study to learn more, and let us know how you’re optimizing your disclosure process.

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Biotech Weekly Commentary (Apr. 23 – Apr. 27)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of Apr. 23– Apr. 27, 2012

Sector indices advanced with earnings in focus. Gains in the BTK and NBI exceeded those in the major US averages. For the week, the BTK advanced 3.51% to 1480.90, and the NBI climbed 3.33% to 1308.96.

 

REGULATORY

Reuters reported on Friday U.S. health regulators approved Vivus’ Avanafil treatment for erectile dysfunction. Vivus gained 2.95% to $25.15. 

Amgen announced on Friday the FDA has issued a CRL for the sBLA for XGEVA (denosumab) to treat men with castration-resistant prostate cancer at high risk of developing bone metastases.  The FDA determined that the effect on bone metastases-free survival was of insufficient magnitude to outweigh the risks (including osteonecrosis of the jaw) of XGEVA in the intended population, and requested data from an adequate and well-controlled trial(s) demonstrating a favorable risk-benefit profile for XGEVA that is generalizable to the U.S. population. Amgen climbed 1.20% to $71.64.

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Biotech Weekly Commentary (Apr. 16 – Apr. 20)

Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts.  Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos.  Read the report.  Interested in getting similar commentaries on a daily basis – before the market opens and following the close?  Leave a comment to let us know.

 

Week of Apr. 16– Apr. 20, 2012

Sector indices outperformed majorUSaverages, fueled late in the week by M&A newsflow and clinical pipeline updates at EASL. For the week, the BTK rallied 8.10% to 1430.56, and the NBI climbed 3.24% to 1266.72.

 

REGULATORY

AstraZeneca and Bristol-Myers Squibb announced the CHMP recommended the approval of FORXIGA (dapagliflozin) tablets for the treatment of Type II diabetes, as an adjunct to diet and exercise, in combination with other glucose-lowering medicinal products including insulin, and as a monotherapy in metformin intolerant patients. AstraZeneca gained 1.83% to $38.73 on Friday, and Bristol-Myers Squibb rose 0.88% to $34.23.

Novartis announced the CHMP adopted a positive opinion for Jakavi (INC424, ruxolitinib) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. In addition, the company announced that the CHMP confirmed a positive benefit-risk profile of once-daily oral Gilenya (fingolimod). Novartis and the CHMP have agreed to recommended updates to the product information in the EU in order to provide further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients. Novartis rose 1.64% to $56.38 on Friday.

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