Commenting on Pfizer’s planned $350 million investment in a biosimilars plant in China, Reuters noted that global "Big Pharma" is increasingly looking for smart ways to tap China's healthcare market, estimated by consultancy IMS Health to be worth around $185 billion by 2018. From investing in China facilities to acquisitions, licensing deals and joint ventures, the aim is to seek an edge in dealings with domestic regulators and government.
Pharmaceutical executives have long complained about the slow process of getting drugs to market in China, while others have run up against regulatory roadblocks, said Reuters. Pfizer had to close its vaccine business in the country last year after a licence for its top-selling vaccine Prevenar was not renewed.
One of the biggest stories of last week was the huge rise of Tesaro, shares of which more than doubled in the week. The catalyst for the huge rally was very encouraging Phase III trial data for its PARP inhibitor niraparib in women with ovarian cancer that should lead to commercial approval, commented Bret Jensen writing on the Seeking Alpha blog.
Currently, there is no approved therapy in the USA for maintenance treatment of patients with recurrent ovarian cancer following response to platinum. The company should file New Drug Applications (NDAs) in the USA and Europe sometime in the fourth quarter. Tesaro certainly took no time to take advantage of the great news by announcing a $300 million secondary offering the day after this news caused its stock to double. Even this dilution was not enough to keep investors from continuing to bid up its shares, however, Mr Jensen noted.
News for Harvoni’s competition
The hepatitis C space is currently dominated by Gilead Science’s Harvoni. However, Regulus released some very important news about its hepatitis C virus (HCV) drug candidate on Monday, observed Jonathan Weber, writing on Seeking Alpha. The company's product candidate RG-101 for the treatment of hepatitis C virus infections has caused a second severe adverse effect (SAE) in a patient who is enrolled in Regulus' Phase I study of RG-101. The FDA has notified Regulus that the company's Investigational New Drug Application for RG-101 has been put on clinical hold, which means that Regulus is not allowed to enroll new patients for clinical testing of its drug candidate RG-101. The drug thus looks pretty much like a failed drug candidate right now, which explains the market's reaction the Monday's news.
After news about the second SAE of a patient treated with RG-101 got public Regulus' shares dropped 50%, and are currently trading at below $3.00, more than 75% below the 52 week high of $11.59.
The takeaway on this, says Mr Weber, is that, with RG-101's safety issues getting public and the FDA's issuance of a clinical hold, it looks like the drug will have a lot of problems getting approval at all, which lead to the huge drop in Regulus' share price. This also means that this is one competitor Gilead Sciences' investors don't have to worry about any longer (or rather: It is now clear that investors had no reason to worry about Regulus' RG-101 in the first place).
GW Pharmaceuticals got the second win it needed. Success for epidiolex in the first of two studies in Lennox-Gastaut syndrome helped push its already sky-high valuation up another 13% as the cannabis-based treatment now looks to be effective in a wider spectrum of treatment-resistant epilepsies, commented EP Vantage, the editorial arm of the Evaluate group.
Results from a confirmatory Lennox-Gastaut trial are due before October, but with a robust-looking benefit in seizure reduction shown in this first trial it would be a bombshell if the second were to fail. Regulatory filings are due early next year, and the group is ploughing ahead with a plan for solo launch.
Why Teva Pharma continues to sell assets
In the latest development, Israel’s Teva Pharmaceuticals Industries has agreed to sell its US generic products division to Australia's Mayne Pharma for $652 million. While Mayne will benefit from diversifying into new drug segments and adding new product categories to its portfolio, what’s in it for Teva Pharma? asks Shobhit Seth rhetorically writing in Investopedia.
Teva Pharma has been on a selling spree recently, as a result of divestments required by competition authorities relating to its acquisition of the Allergan Generics business. The $652 million sale to Mayne Pharma follows the recent sales of its other assets to different pharma companies across the globe. The buyers include Dr Reddy's Laboratories (deal worth $350 million), Impax Laboratories ($586 million), Sagent Pharmaceuticals ($40 million) and Cadila Healthcare. Teva is also progressing to sale its Irish and UK generics businesses, which are expected to fetch around $1.3 billion.
While Allergan will receive Teva shares worth $6.75 billion, the remaining $33.75 billion is to be paid in cash. All the proceeds from such asset sales will be utilized for Teva’s acquisition of Allergan, which is aimed towards creating a transformative generics and specialty pharma company. Teva seems to be on the right track with the intended asset sales across the globe. However, some delay may be expected till the final execution for the much awaited Allergan deal, Mr Seth concluded.
Sanofi and Boehringer Ingelheim signing contracts on their animal health/consumer business swap raises the obvious question of what the French company might do with its 4.7 billion ($5.2 billion) windfall when the deal closes later this year.
But, given the turmoil after the UK’s EU membership referendum result, a more fundamental observation might be that the deal is going ahead without any amendment to its terms. EvaluatePharma calculates that $102 billion of open deals in healthcare have yet to be completed, and the euro dipping 2.5% against the US dollar since Thursday might have several companies fretting about their fate.
Indeed, Sanofi, should itself privately be evaluating its ability to pay up for Medivation, given that it is a European company reporting in euros trying to buy a US biotech in dollars. However, for now the French group is playing hardball, trying to oust Medivation's directors rather than putting a sweetened bid on the table.
Pharmaceutical executives have long complained about the slow process of getting drugs to market in China, while others have run up against regulatory roadblocks, said Reuters. Pfizer had to close its vaccine business in the country last year after a licence for its top-selling vaccine Prevenar was not renewed.
One of the biggest stories of last week was the huge rise of Tesaro, shares of which more than doubled in the week. The catalyst for the huge rally was very encouraging Phase III trial data for its PARP inhibitor niraparib in women with ovarian cancer that should lead to commercial approval, commented Bret Jensen writing on the Seeking Alpha blog.
Currently, there is no approved therapy in the USA for maintenance treatment of patients with recurrent ovarian cancer following response to platinum. The company should file New Drug Applications (NDAs) in the USA and Europe sometime in the fourth quarter. Tesaro certainly took no time to take advantage of the great news by announcing a $300 million secondary offering the day after this news caused its stock to double. Even this dilution was not enough to keep investors from continuing to bid up its shares, however, Mr Jensen noted.
News for Harvoni’s competition
The hepatitis C space is currently dominated by Gilead Science’s Harvoni. However, Regulus released some very important news about its hepatitis C virus (HCV) drug candidate on Monday, observed Jonathan Weber, writing on Seeking Alpha. The company's product candidate RG-101 for the treatment of hepatitis C virus infections has caused a second severe adverse effect (SAE) in a patient who is enrolled in Regulus' Phase I study of RG-101. The FDA has notified Regulus that the company's Investigational New Drug Application for RG-101 has been put on clinical hold, which means that Regulus is not allowed to enroll new patients for clinical testing of its drug candidate RG-101. The drug thus looks pretty much like a failed drug candidate right now, which explains the market's reaction the Monday's news.
After news about the second SAE of a patient treated with RG-101 got public Regulus' shares dropped 50%, and are currently trading at below $3.00, more than 75% below the 52 week high of $11.59.
The takeaway on this, says Mr Weber, is that, with RG-101's safety issues getting public and the FDA's issuance of a clinical hold, it looks like the drug will have a lot of problems getting approval at all, which lead to the huge drop in Regulus' share price. This also means that this is one competitor Gilead Sciences' investors don't have to worry about any longer (or rather: It is now clear that investors had no reason to worry about Regulus' RG-101 in the first place).
GW Pharmaceuticals got the second win it needed. Success for epidiolex in the first of two studies in Lennox-Gastaut syndrome helped push its already sky-high valuation up another 13% as the cannabis-based treatment now looks to be effective in a wider spectrum of treatment-resistant epilepsies, commented EP Vantage, the editorial arm of the Evaluate group.
Results from a confirmatory Lennox-Gastaut trial are due before October, but with a robust-looking benefit in seizure reduction shown in this first trial it would be a bombshell if the second were to fail. Regulatory filings are due early next year, and the group is ploughing ahead with a plan for solo launch.
Why Teva Pharma continues to sell assets
In the latest development, Israel’s Teva Pharmaceuticals Industries has agreed to sell its US generic products division to Australia's Mayne Pharma for $652 million. While Mayne will benefit from diversifying into new drug segments and adding new product categories to its portfolio, what’s in it for Teva Pharma? asks Shobhit Seth rhetorically writing in Investopedia.
Teva Pharma has been on a selling spree recently, as a result of divestments required by competition authorities relating to its acquisition of the Allergan Generics business. The $652 million sale to Mayne Pharma follows the recent sales of its other assets to different pharma companies across the globe. The buyers include Dr Reddy's Laboratories (deal worth $350 million), Impax Laboratories ($586 million), Sagent Pharmaceuticals ($40 million) and Cadila Healthcare. Teva is also progressing to sale its Irish and UK generics businesses, which are expected to fetch around $1.3 billion.
While Allergan will receive Teva shares worth $6.75 billion, the remaining $33.75 billion is to be paid in cash. All the proceeds from such asset sales will be utilized for Teva’s acquisition of Allergan, which is aimed towards creating a transformative generics and specialty pharma company. Teva seems to be on the right track with the intended asset sales across the globe. However, some delay may be expected till the final execution for the much awaited Allergan deal, Mr Seth concluded.
Sanofi and Boehringer Ingelheim signing contracts on their animal health/consumer business swap raises the obvious question of what the French company might do with its 4.7 billion ($5.2 billion) windfall when the deal closes later this year.
But, given the turmoil after the UK’s EU membership referendum result, a more fundamental observation might be that the deal is going ahead without any amendment to its terms. EvaluatePharma calculates that $102 billion of open deals in healthcare have yet to be completed, and the euro dipping 2.5% against the US dollar since Thursday might have several companies fretting about their fate.
Indeed, Sanofi, should itself privately be evaluating its ability to pay up for Medivation, given that it is a European company reporting in euros trying to buy a US biotech in dollars. However, for now the French group is playing hardball, trying to oust Medivation's directors rather than putting a sweetened bid on the table.
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