Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.
This week, January 22-26, 2018, we had thoughts on the following: Chiesi could see a return on its Zymenex buy; better late than never for Astra’s respiratory triple; Cannimed and Aurora light peace pipe to strike C$1bn deal; investors exit on a high as J&J’s growth promises fail to convince; Honda’s walking aid comes to Europe; Indivior capitalises on Camarus and Braeburn’s opioid pain; US government shutdown not too damaging for biopharma… yet.
These snippets were previously published daily via twitter.
Chiesi could see a return on its Zymenex buy
January 26, 2018
The likely approval of Chiesi’s Lamzede in the EU could justify the Italian group’s low-key 2013 acquisition of the project’s originator, the private Danish company Zymenex. And it will have been achieved under pretty unusual conditions: recommending approval today the EU CHMP admitted that the one-year period of Lamzede’s 25-subject pivotal trial was insufficient to characterise the magnitude of changes seen. However, the agency gave Lamzede its blessing “under exceptional circumstances”, citing the rarity of the disease in question, alpha-mannosidosis, and asking Chiesi to run a confirmatory open-label trial. It said this rare inherited enzyme disorder, which occurs in children and adults, has no cure, though patients with less severe forms can be managed with supportive care. Lamzede contains velmanase alfa, a recombinant alpha mannosidase, and attempts to replace the enzyme that sufferers are unable to produce. What Chiesi stands to make from an approval is as yet unclear, as Lamzede does not appear in most analysts’ forecasts, and the value of the group’s Zymenex takeover was never disclosed.
Better late than never for Astra’s respiratory triple
January 26, 2018
There was a time when positive pivotal data on a triple combo for COPD would have been greeted with excitement, but unfortunately for Astrazeneca that time has passed. Still, assuming that US generic versions of Glaxo’s Advair continue to be delayed, Astra’s PT010 might still be in with a chance to make a small impression on the COPD space, having today met eight of nine endpoints related to lung function in the phase III Kronos trial. The comparator – of course – was not PT010’s ingredients, budesonide, formoterol and glycopyrrolate, dosed individually, but rather dual combinations containing formoterol plus either glycopyrronium or budesonide. Curiously, Astra said it would pursue Japan and China filings first, this year, before putting PT010 before US and Europe regulators in 2019. The asset, derived from Astra’s 2013 $560m acquisition of Pearl Therapeutics, will compete against Glaxo’s recently approved triple, Trelegy Ellipta, and Chiesi’s Trimbow, as well as Advair generics, whenever these appear.
Cannimed and Aurora light peace pipe to strike C$1bn deal
January 25, 2018
One can only imagine how two warring Canadian cannabis companies managed to overcome months of acrimony to strike a deal that will see Aurora Cannabis take out Cannimed for C$1.1bn ($892m). Alongside any surprise over the fact that they managed to settle their differences is the revelation that Aurora will have a valuation of C$7.4bn ($6bn) after the transaction. Stocks of companies growing cannabis have rocketed this year ahead of Canada’s decision to legalise sales of the plant by the summer. This has led to a buying frenzy among rivals to gain scale, and stratospheric company valuations. The competition for assets was demonstrated by Aurora having to up its original offer by 79% to secure Cannimed. By choosing Cannimed Aurora could be signalling its intentions not only to capture a large slice of the domestic recreational market, but the growing global medical marijuana sector too. Cannimed has collaborations with academic institutions and one product in a phase I trial for childhood epilepsy. Australia, Germany and parts of the US – at the state level – already allow the use of medical marijuana. With more countries expected to embrace medical marijuana and concerns about a bubble in the Canadian cannabis market Aurora’s double play, while costly, could be wise.
Investors exit on a high as J&J’s growth promises fail to convince
January 23, 2018
Johnson & Johnson kicked off big pharma’s fourth-quarter earnings season by providing the sector with the first glimpse at the accounting impact of the US tax reforms – the company took a huge $13.6bn charge on the cost of implementing the changes, which will include repatriating some of its substantial ex-US cash pile. Investors responded poorly to the numbers, however, sending shares in the diversified healthcare giant down 2.7%. Upbeat growth expectations across all divisions this year failed to convince, with shareholders apparently rattled by a clarification to the company’s sales growth guidance for 2018. Having forecast 3.5-4.5% growth in a press release, executives on a conference call said this could be around 1 percentage point lower if planned acquisitions and divestments did not happen. Few details were given on what these might look like – options for units beyond the diabetes division are being evaluated, executives said, adding that they favour earlier-stage deals and enjoy the flexibility to evaluate all acquisition options. J&J had a pretty successful 2017 on the stock market – its 27% gain over the year ranked it third-best big performer among big cap pharma, and its shares closed at a record high yesterday. Perhaps investors are betting that the trick is unlikely to be repeated.
Honda’s walking aid comes to Europe
January 23, 2018
Sales of robotic exoskeletons to help paralysed people to walk are starting to take off, with Rewalk Robotics and Cyberdyne starting to have annual sales in the tens of millions of dollars. Honda has taken a slightly different approach. Its Walking Assist Device, which has been CE marked for sale in Europe, is intended to help people who can walk on their own but who need assistance, for example to aid with rehabilitation. Honda’s device weighs about 2.7kg and is similar to a belt with motorised struts strapped to the thighs. Using hip angle sensors, the motors provide assistance to the patient’s leg muscles, improving the timing of each leg lifting and lengthening the stride. The device can also help with bending and extending both legs. The product is being used at around 250 facilities in Japan, but Honda’s medical robotics sales are likely a long way behind Rewalk’s, and even more behind fellow Japanese group Cyberdyne’s. It is just as well they are not direct competitors.
Indivior capitalises on Camarus and Braeburn’s opioid pain
January 22, 2018
As ever in the world of drug discovery one company’s misery is another’s gain. This was proved again today as shares in Indivior rose 4% and hit new highs after the weekend’s complete response letter for Camurus and Braeburn Pharmaceuticals’ opioid addiction project CAM2038. With no extra clinical trials requested by the FDA CAM2038 is now looking at a minimum six to 12-month delay before it can even possibly be considered for approval again. This will give Indivior’s rival product Sublocade a valuable headstart, and could help it establish itself as the product of choice for physicians looking to curb patients’ opioid abuse. Sublocade is due to be launched this quarter. Even without the benefit of hindsight, CAM2038’s chances of approval looked a lot slimmer than Sublocade’s after an FDA advisory committee expressed reservations about CAM2083 studies, but this is one of the rare examples of the FDA going against the recommendation of one of its committees. With Sublocade now taking the lead the only hope for CAM2038 will be a swift turnaround and trying to win market share through pricing.
US government shutdown not too damaging for biopharma… yet
January 22, 2018
The US Congress’s expected votes today to reopen federal government operations temporarily after a one-day shutdown should not severely disrupt biopharma companies’ plans to submit new drug applications. However, without agreement on a fiscal 2018 budget there is still the risk of another shutdown in coming weeks. After the US Senate failed to pass a spending bill by midnight last Friday non-essential US government functions were shut down for lack of funding – this included the FDA’s ability to accept new drug filings today, although review functions supported by industry user fees that were already under way were able to continue as usual. Normal government functions will likely resume tomorrow. The agreement reached by Senate leaders will allow for passage of a bill that will fund the government through February 8 while negotiations over immigration and a children’s health insurance programme can be concluded.