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Biotech Stock Roundup: EU Label Expansion for Alexion, BIIB Facing Drug Price Probe
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Alexion Pharmaceuticals got a boost with the EU approving its key revenue driver Soliris for an additional indication. Meanwhile, Biogen (BIIB - Free Report) was in the news with an investigation being launched into the rising prices of multiple sclerosis ("MS") drugs. The investigation has been launched by Rep. Elijah E. Cummings and Rep. Peter Welch with letters being sent to seven companies including Biogen requesting information about their pricing strategies for their MS drugs.
Recap of the Week’s Most Important Stories
EU Label Expansion for Alexion’s Soliris: Alexion’s flagship product, Soliris, gained EU approval for the treatment of patients with refractory generalized myasthenia gravis (gMG) making it the first and only complement-based therapy approved in the EU for an ultra-rare subset of gMG. Alexion will launch Soliris for this indication initially in Germany and is evaluating additional EU launches.
The gMG indication represents incremental growth opportunity for Soliris and enables the company to enter the neurology therapeutic area. Soliris is currently under review in the U.S. and Japan (response expected early next year) for the gMG indication. With the EU granting approval, it looks like Soliris will gain approval in the U.S. as well where a decision is expected by Oct 23, 2017. According to information provided by the company, about 60,000 – 80,000 people in the U.S. suffer from myasthenia gravis (MG) – Alexion’s targeted population will be approximately 5%-10% of the total MG patient population. Results from a late-stage study (REGAIN) conducted by the company indicate that about 60% of these refractory gMG patients will respond to treatment with Soliris.
Soliris is Alexion’s key growth driver with the drug bringing in sales of $1.6 billion in the first half of 2017. The company expects Soliris revenues of $3,075 - $3,125 million in 2017, assuming the identification of a steady number of new patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) across the globe (Also read: Alexion's Soliris' Label Expansion Approved in Europe).
Biogen & Others Face MS Drug Price Probe: Biogen, which holds a strong position in the MS market, has been asked to submit information on five MS drugs – Avonex, Tysabri, Tecfidera, Plegridy and Zinbryta (co-promoted with AbbVie). According to the letter, four of these drugs have seen at least double-digit price increases since approval while the price of one drug has increased by almost 1,000%. Moreover, Zinbryta, was introduced at a price of $86,592 per annum in 2016 and the price of Biogen’s other four MS drugs were hiked to match Zinbryta’s price by 2017. Biogen will have to respond to the letter by Aug 31, 2017 (Also read: Biogen & 6 Other Multiple Sclerosis Drug Stocks in Focus: Here's Why).
Pipeline Setback for Ultragenyx: Ultragenyx Pharmaceutical (RARE - Free Report) , a company focused on developing treatments for rare and ultra-rare diseases, suffered a pipeline setback with one of its candidates failing in a late-stage study. Aceneuramic acid extended release (Ace-ER) failed to meet the primary as well as key secondary endpoints in a phase III study in patients with GNE myopathy ("GNEM"). Ultragenyx has decided to discontinue the development of Ace-ER.
Ultragenyx currently has an investigational treatment under FDA review (vestronidase alpha for MPS 7 with a decision expected by Nov 16, 2017) while it is looking to file for FDA approval of burosumab (for X-linked hypophosphatemia) shortly.
FDA Nod for Ironwood Gout Drug: Ironwood Pharmaceuticals’ (IRWD - Free Report) once-daily gout treatment gained FDA approval. Duzallo has been approved for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone. This makes Duzallo the first FDA-approved fixed-dose combination treatment available in a single pill for addressing both causes of hyperuricemia in gout - over-production and under-excretion of serum uric acid. Ironwood expects to launch the product in the fourth quarter. Ironwood expects Duzallo to drive sales of its gout franchise which is expected to deliver total annual peak sales of more than $300 million in the U.S. We note that Duzallo’s label includes a boxed warning about acute renal failure (Also read: Ironwood Pharma's Combination Gout Drug Gets FDA Approval).
Alkermes Starts Rolling NDA Submission for MDD Drug: Alkermes (ALKS - Free Report) has started the rolling submission of a new drug application (NDA) for its investigational major depressive disorder (MDD) drug, ALKS 5461. The rolling NDA submission for the once-daily, oral medicine with a novel mechanism of action for the adjunctive treatment of MDD is slated to complete by year end (Also read: Alkermes Initiates Rolling Submission of Depression Drug). ALKS 5461 has fast track designation in the U.S. Alkermes has lost 9.9% of its value year to date versus the 5.2% growth of its industry.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index inched up slightly (0.4%) over the last five trading sessions. Among major biotech stocks, Alexion was up 2.2% while Celgene lost 0.8%. Over the last six months, Vertex (VRTX - Free Report) was up 81.2% while Biogen slipped 0.3% (See the last biotech stock roundup here: Regeneron Drops RSV Antibody, Gilead HIV Drug Gets Priority Review).
What's Next in the Biotech World?
Watch out for the usual regulatory and pipeline updates. Amgen (AMGN - Free Report) will be presenting new data on its PCSK9 inhibitor, Repatha, at the European Society of Cardiology (ESC) Congress 2017.
4 Surprising Tech Stocks to Keep an Eye on
Tech stocks have been a major force behind the market’s record highs, but picking the best ones to buy can be tough. There’s a simple way to invest in the success of the entire sector. Zacks has just released a Special Report revealing one thing tech companies literally cannot function without. More importantly, it reveals 4 top stocks set to skyrocket on increasing demand for these devices. I encourage you to get the report now – before the next wave of innovations really take off.
Image: Bigstock
Biotech Stock Roundup: EU Label Expansion for Alexion, BIIB Facing Drug Price Probe
Alexion Pharmaceuticals got a boost with the EU approving its key revenue driver Soliris for an additional indication. Meanwhile, Biogen (BIIB - Free Report) was in the news with an investigation being launched into the rising prices of multiple sclerosis ("MS") drugs. The investigation has been launched by Rep. Elijah E. Cummings and Rep. Peter Welch with letters being sent to seven companies including Biogen requesting information about their pricing strategies for their MS drugs.
Recap of the Week’s Most Important Stories
EU Label Expansion for Alexion’s Soliris: Alexion’s flagship product, Soliris, gained EU approval for the treatment of patients with refractory generalized myasthenia gravis (gMG) making it the first and only complement-based therapy approved in the EU for an ultra-rare subset of gMG. Alexion will launch Soliris for this indication initially in Germany and is evaluating additional EU launches.
The gMG indication represents incremental growth opportunity for Soliris and enables the company to enter the neurology therapeutic area. Soliris is currently under review in the U.S. and Japan (response expected early next year) for the gMG indication. With the EU granting approval, it looks like Soliris will gain approval in the U.S. as well where a decision is expected by Oct 23, 2017. According to information provided by the company, about 60,000 – 80,000 people in the U.S. suffer from myasthenia gravis (MG) – Alexion’s targeted population will be approximately 5%-10% of the total MG patient population. Results from a late-stage study (REGAIN) conducted by the company indicate that about 60% of these refractory gMG patients will respond to treatment with Soliris.
Soliris is Alexion’s key growth driver with the drug bringing in sales of $1.6 billion in the first half of 2017. The company expects Soliris revenues of $3,075 - $3,125 million in 2017, assuming the identification of a steady number of new patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) across the globe (Also read: Alexion's Soliris' Label Expansion Approved in Europe).
Alexion is a Zacks Rank #1 (Strong Buy) stock. You can see the complete list of today’s Zacks #1 Rank stocks here.
Biogen & Others Face MS Drug Price Probe: Biogen, which holds a strong position in the MS market, has been asked to submit information on five MS drugs – Avonex, Tysabri, Tecfidera, Plegridy and Zinbryta (co-promoted with AbbVie). According to the letter, four of these drugs have seen at least double-digit price increases since approval while the price of one drug has increased by almost 1,000%. Moreover, Zinbryta, was introduced at a price of $86,592 per annum in 2016 and the price of Biogen’s other four MS drugs were hiked to match Zinbryta’s price by 2017. Biogen will have to respond to the letter by Aug 31, 2017 (Also read: Biogen & 6 Other Multiple Sclerosis Drug Stocks in Focus: Here's Why).
Pipeline Setback for Ultragenyx: Ultragenyx Pharmaceutical (RARE - Free Report) , a company focused on developing treatments for rare and ultra-rare diseases, suffered a pipeline setback with one of its candidates failing in a late-stage study. Aceneuramic acid extended release (Ace-ER) failed to meet the primary as well as key secondary endpoints in a phase III study in patients with GNE myopathy ("GNEM"). Ultragenyx has decided to discontinue the development of Ace-ER.
Ultragenyx currently has an investigational treatment under FDA review (vestronidase alpha for MPS 7 with a decision expected by Nov 16, 2017) while it is looking to file for FDA approval of burosumab (for X-linked hypophosphatemia) shortly.
FDA Nod for Ironwood Gout Drug: Ironwood Pharmaceuticals’ (IRWD - Free Report) once-daily gout treatment gained FDA approval. Duzallo has been approved for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone. This makes Duzallo the first FDA-approved fixed-dose combination treatment available in a single pill for addressing both causes of hyperuricemia in gout - over-production and under-excretion of serum uric acid. Ironwood expects to launch the product in the fourth quarter. Ironwood expects Duzallo to drive sales of its gout franchise which is expected to deliver total annual peak sales of more than $300 million in the U.S. We note that Duzallo’s label includes a boxed warning about acute renal failure (Also read: Ironwood Pharma's Combination Gout Drug Gets FDA Approval).
Alkermes Starts Rolling NDA Submission for MDD Drug: Alkermes (ALKS - Free Report) has started the rolling submission of a new drug application (NDA) for its investigational major depressive disorder (MDD) drug, ALKS 5461. The rolling NDA submission for the once-daily, oral medicine with a novel mechanism of action for the adjunctive treatment of MDD is slated to complete by year end (Also read: Alkermes Initiates Rolling Submission of Depression Drug). ALKS 5461 has fast track designation in the U.S. Alkermes has lost 9.9% of its value year to date versus the 5.2% growth of its industry.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index inched up slightly (0.4%) over the last five trading sessions. Among major biotech stocks, Alexion was up 2.2% while Celgene lost 0.8%. Over the last six months, Vertex (VRTX - Free Report) was up 81.2% while Biogen slipped 0.3% (See the last biotech stock roundup here: Regeneron Drops RSV Antibody, Gilead HIV Drug Gets Priority Review).
What's Next in the Biotech World?
Watch out for the usual regulatory and pipeline updates. Amgen (AMGN - Free Report) will be presenting new data on its PCSK9 inhibitor, Repatha, at the European Society of Cardiology (ESC) Congress 2017.
4 Surprising Tech Stocks to Keep an Eye on
Tech stocks have been a major force behind the market’s record highs, but picking the best ones to buy can be tough. There’s a simple way to invest in the success of the entire sector. Zacks has just released a Special Report revealing one thing tech companies literally cannot function without. More importantly, it reveals 4 top stocks set to skyrocket on increasing demand for these devices. I encourage you to get the report now – before the next wave of innovations really take off.
See Stocks Now>>