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Biotech Stock Roundup: Acorda Down on Court Ruling, Patent Challenge for CELG Drug
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Quite a few companies provided patent related updates this week. Meanwhile, Paratek’s shares soared on positive late-stage data.
Recap of the Week’s Most Important Stories
Acorda Slumps on Court Ruling: Acorda suffered a big setback in a patent infringement lawsuit for its flagship drug, Ampyra, with the United States District Court for the District of Delaware upholding only one of the 5 patents that were challenged. The court ruling comes just a few days after the company had got a favorable ruling in an inter partes review.
However, with the recent court ruling, Acorda could well start facing generic competition for Ampyra from the third quarter of 2018 if it fails in its appeal efforts. The patent that was upheld by the court is set to expire in Jul 2018. Acorda’s shares plunged 21.5% on the ruling.
United Therapeutics Faces RemoSynch Delay: United Therapeutics was also hit by news about a regulatory delay which will result in the postponement of the company’s planned launch of the RemoSynch Implantable System in the U.S. The company said that the launch is now expected next year instead of 2017. RemoSynch, developed in collaboration with Medtronic, is designed to deliver Remodulin for the treatment of patients with pulmonary arterial hypertension. The company also got an unfavorable ruling in an inter partes review regarding a patent covering treprostinil, the key component of Remodulin injection, Tyvaso inhalation solution, and Orenitram extended-release tablets (Read more: United Therapeutics Tanks, Remodulin Pump Launch Delayed).
Paratek Soars on Phase III Data: Paratek’s shares jumped 22.9% with the company announcing positive top-line results from a pivotal late-stage study on its lead pipeline candidate, omadacycline (a once-daily oral and IV, broad spectrum investigational antibiotic), for the treatment of patients with community-acquired bacterial pneumonia (CABP). This is the second positive phase III registration study (the other being for acute bacterial skin and skin structure infections (ABSSSI)) on omadacycline and the company expects to file for FDA approval in the first quarter of 2018 and EU approval later in 2018.
These results come just a few days after the company and its partner Allergan had reported positive phase III data on another late-stage drug, sarecycline, for the potential treatment of acne. The companies intend to file for FDA approval in the second half of the year (Read more: Allergan Acne Candidate Meets Endpoints in Phase III Studies).
Patent Challenge for Celgene’s Pomalyst: Celgene is facing a patent challenge for its multiple myeloma treatment Pomalyst with Teva filing a Para IV challenge. Teva is looking to gain FDA approval for its generic version of the drug. Celgene is currently evaluating the notice and will most likely file a patent infringement lawsuit. The entry of generic Pomalyst would be a setback for the company -- Pomalyst achieved blockbuster status last year with sales growing 33.3% to $1.3 billion. Despite the growing presence of new therapies and later lines of treatment, Pomalyst has managed to maintain its leadership position in the third and fourth-line plus patient segment in major markets. FDA approval for the use of Pomalyst in combination with Darzalex (daratumumab) for relapsed refractory myeloma by Jun 2017 would boost revenues further. Pomalyst is being evaluated for use in combination with other treatments as well and is expected to grow 22% in 2017.
Kite Finishes Rolling BLA Submission: Kite Pharma has finished submitting its rolling BLA in the U.S. for its lead pipeline candidate, axicabtagene ciloleucel. The company is looking to get the CAR-T therapy approved for the treatment of patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT). Priority review followed by FDA approval would allow Kite to launch the product this year itself (Read more: Kite Pharma Completes Filing for CAR-T Therapy with FDA).
Axicabtagene ciloleucel has Breakthrough Therapy Designation (BTD) in the U.S. for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL). Kite expects to seek approval from the European Medicines Agency (EMA) in 2017.
Halozyme Down on Study Update: Halozyme’s shares were down 8.8% on an update provided by the company on its lead pipeline program, PEGPH20, with enrolment in a study being temporarily halted on a futility analysis. The company said that SWOG (an independent network of researchers that design and conduct cancer studies) informed Halozyme that enrolment in the SWOG phase Ib/II study on PEGPH20 plus modified FOLFIRINOX chemotherapy versus modified FOLFIRINOX alone in patients with previously untreated metastatic pancreas cancer has been temporarily closed. A planned early futility analysis by the independent Data Monitoring Committee showed that the addition of PEGPH20 every two weeks to modified FOLFIRINOX would not be likely to show a statistically significant improvement in overall survival compared to the chemo arm.
Opdivo-Epacadostat Combination to Move into Phase III: Incyte and Bristol-Myers will be moving their clinical development program for Incyte’s investigational oral selective IDO1 enzyme inhibitor, epacadostat, plus Bristol-Myers’ PD-1 immune checkpoint inhibitor, Opdivo, into phase III registrational studies. The studies will evaluate the combination in first-line non-small cell lung cancer across the spectrum of PD-L1 expression and first-line head and neck cancer. The companies also said that they are expanding a phase I/II study (Read more: Bristol-Myers, Incyte to Advance Clinical Program). Incyte’s shares were up on the news.
Amgen Looks to Expand Xgeva Label: Amgen (AMGN - Free Report) is looking to get Xgeva's label expanded in both the U.S. and EU to include its use for the prevention of skeletal-related events (SREs) in patients with multiple myeloma. Xgeva, which brought in sales of $1.5 billion in 2016, is currently approved for the prevention of SREs in solid tumors. Expansion into the multiple myeloma patient population would boost sales. Amgen is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined slightly (0.15%) over the last five trading sessions. Among major biotech stocks, Amgen declined 0.2% while Vertex (VRTX - Free Report) shot up 25.2% following the release of positive data from a couple of late-stage studies evaluating a combination of tezacaftor and Kalydeco (ivacaftor). Over the last six months, Vertex was up 29.9% while Gilead (GILD - Free Report) was down 13.3% (See the last biotech stock roundup here: Regeneron, Tesaro Drugs Approved, Vertex Scores Big in Study).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates.
Now See Our Private Investment Ideas
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Biotech Stock Roundup: Acorda Down on Court Ruling, Patent Challenge for CELG Drug
Quite a few companies provided patent related updates this week. Meanwhile, Paratek’s shares soared on positive late-stage data.
Recap of the Week’s Most Important Stories
Acorda Slumps on Court Ruling: Acorda suffered a big setback in a patent infringement lawsuit for its flagship drug, Ampyra, with the United States District Court for the District of Delaware upholding only one of the 5 patents that were challenged. The court ruling comes just a few days after the company had got a favorable ruling in an inter partes review.
However, with the recent court ruling, Acorda could well start facing generic competition for Ampyra from the third quarter of 2018 if it fails in its appeal efforts. The patent that was upheld by the court is set to expire in Jul 2018. Acorda’s shares plunged 21.5% on the ruling.
Year-to-date, Acorda has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares declining almost 4% compared to the industry gain of 3.3% (Read more: Acorda's MS Drug Patents Invalidated, Shares Plunge).
United Therapeutics Faces RemoSynch Delay: United Therapeutics was also hit by news about a regulatory delay which will result in the postponement of the company’s planned launch of the RemoSynch Implantable System in the U.S. The company said that the launch is now expected next year instead of 2017. RemoSynch, developed in collaboration with Medtronic, is designed to deliver Remodulin for the treatment of patients with pulmonary arterial hypertension. The company also got an unfavorable ruling in an inter partes review regarding a patent covering treprostinil, the key component of Remodulin injection, Tyvaso inhalation solution, and Orenitram extended-release tablets (Read more: United Therapeutics Tanks, Remodulin Pump Launch Delayed).
Paratek Soars on Phase III Data: Paratek’s shares jumped 22.9% with the company announcing positive top-line results from a pivotal late-stage study on its lead pipeline candidate, omadacycline (a once-daily oral and IV, broad spectrum investigational antibiotic), for the treatment of patients with community-acquired bacterial pneumonia (CABP). This is the second positive phase III registration study (the other being for acute bacterial skin and skin structure infections (ABSSSI)) on omadacycline and the company expects to file for FDA approval in the first quarter of 2018 and EU approval later in 2018.
These results come just a few days after the company and its partner Allergan had reported positive phase III data on another late-stage drug, sarecycline, for the potential treatment of acne. The companies intend to file for FDA approval in the second half of the year (Read more: Allergan Acne Candidate Meets Endpoints in Phase III Studies).
Patent Challenge for Celgene’s Pomalyst: Celgene is facing a patent challenge for its multiple myeloma treatment Pomalyst with Teva filing a Para IV challenge. Teva is looking to gain FDA approval for its generic version of the drug. Celgene is currently evaluating the notice and will most likely file a patent infringement lawsuit. The entry of generic Pomalyst would be a setback for the company -- Pomalyst achieved blockbuster status last year with sales growing 33.3% to $1.3 billion. Despite the growing presence of new therapies and later lines of treatment, Pomalyst has managed to maintain its leadership position in the third and fourth-line plus patient segment in major markets. FDA approval for the use of Pomalyst in combination with Darzalex (daratumumab) for relapsed refractory myeloma by Jun 2017 would boost revenues further. Pomalyst is being evaluated for use in combination with other treatments as well and is expected to grow 22% in 2017.
Kite Finishes Rolling BLA Submission: Kite Pharma has finished submitting its rolling BLA in the U.S. for its lead pipeline candidate, axicabtagene ciloleucel. The company is looking to get the CAR-T therapy approved for the treatment of patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT). Priority review followed by FDA approval would allow Kite to launch the product this year itself (Read more: Kite Pharma Completes Filing for CAR-T Therapy with FDA).
We note that Novartis’ regulatory application for its experimental CAR-T treatment, CTL019, has already been granted priority review by the FDA (Read more: Novartis' CTL109 BLA Gets Priority Review Status from FDA).
Axicabtagene ciloleucel has Breakthrough Therapy Designation (BTD) in the U.S. for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL). Kite expects to seek approval from the European Medicines Agency (EMA) in 2017.
Halozyme Down on Study Update: Halozyme’s shares were down 8.8% on an update provided by the company on its lead pipeline program, PEGPH20, with enrolment in a study being temporarily halted on a futility analysis. The company said that SWOG (an independent network of researchers that design and conduct cancer studies) informed Halozyme that enrolment in the SWOG phase Ib/II study on PEGPH20 plus modified FOLFIRINOX chemotherapy versus modified FOLFIRINOX alone in patients with previously untreated metastatic pancreas cancer has been temporarily closed. A planned early futility analysis by the independent Data Monitoring Committee showed that the addition of PEGPH20 every two weeks to modified FOLFIRINOX would not be likely to show a statistically significant improvement in overall survival compared to the chemo arm.
Opdivo-Epacadostat Combination to Move into Phase III: Incyte and Bristol-Myers will be moving their clinical development program for Incyte’s investigational oral selective IDO1 enzyme inhibitor, epacadostat, plus Bristol-Myers’ PD-1 immune checkpoint inhibitor, Opdivo, into phase III registrational studies. The studies will evaluate the combination in first-line non-small cell lung cancer across the spectrum of PD-L1 expression and first-line head and neck cancer. The companies also said that they are expanding a phase I/II study (Read more: Bristol-Myers, Incyte to Advance Clinical Program). Incyte’s shares were up on the news.
Amgen Looks to Expand Xgeva Label: Amgen (AMGN - Free Report) is looking to get Xgeva's label expanded in both the U.S. and EU to include its use for the prevention of skeletal-related events (SREs) in patients with multiple myeloma. Xgeva, which brought in sales of $1.5 billion in 2016, is currently approved for the prevention of SREs in solid tumors. Expansion into the multiple myeloma patient population would boost sales. Amgen is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined slightly (0.15%) over the last five trading sessions. Among major biotech stocks, Amgen declined 0.2% while Vertex (VRTX - Free Report) shot up 25.2% following the release of positive data from a couple of late-stage studies evaluating a combination of tezacaftor and Kalydeco (ivacaftor). Over the last six months, Vertex was up 29.9% while Gilead (GILD - Free Report) was down 13.3% (See the last biotech stock roundup here: Regeneron, Tesaro Drugs Approved, Vertex Scores Big in Study).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates.
Now See Our Private Investment Ideas
While the above ideas are being shared with the public, other trades are hidden from everyone but selected members. Would you like to peek behind the curtain and view them? Starting today, for the next month, you can follow all Zacks' private buys and sells in real time from value to momentum . . . from stocks under $10 to ETF and option moves . . . from insider trades to companies that are about to report positive earnings surprises (we've called them with 80%+ accuracy). You can even look inside portfolios so exclusive that they are normally closed to new investors. Click here for Zacks' secret trades >>