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23 марта, 16:47

Catalyst Pharma (CPRX) Focused on U.S. Approval for Firdapse

We issued an updated research report on Catalyst Pharmaceuticals, Inc. (CPRX) on Mar 22.

21 марта, 17:54

Jazz Sleep Disorder Drug Positive in Phase III Studies

Jazz Pharmaceuticals plc (JAZZ) recently announced positive efficacy results from two phase III studies evaluating the safety and efficacy of its lead pipeline candidate JZP-110 for the treatment of excessive sleepiness.

21 марта, 16:18

6 Reasons to Invest in GlaxoSmithKline (GSK) Stock in 2017

Glaxo carries a Zacks Rank #2 (Buy).

10 марта, 17:21

Agenus (AGEN) Reports Narrower-than-Expected Loss in Q4

Agenus Inc. (AGEN) reported fourth-quarter 2016 loss of 30 cents per share (including non-cash expenses), narrower than the Zacks Consensus Estimate of a loss of 33 cents but wider than the year-ago loss of 18 cents.

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09 марта, 23:59

Agenus (AGEN) Reports Narrower-than-Expected Q4 Loss

Agenus reported narrower-than-expected loss in the fourth quarter of 2016. Our consensus called for a loss of 33 cents per share, while the company reported a loss of 30 cents.

28 февраля, 17:30

Zacks Industry Outlook Highlights: Johnson & Johnson, Pfizer, Glaxo, Amgen's and Lilly

Zacks Industry Outlook Highlights: Johnson & Johnson, Pfizer, Glaxo, Amgen’s and Lilly

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20 декабря 2016, 17:44

Amgen Files for Approval of Osteoporosis Drug in Japan

Amgen Inc. (AMGN) and partner UCB SA (UCBJF) announced that they have submitted an application seeking marketing approval for its investigational monoclonal antibody romosozumab to Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

16 декабря 2016, 12:21

UCB: Lower standards in Belgium

The last two posts on this blog detail how - for all practical purposes - UCB (the large Belgian pharmaceutical company) has lost the patent to one of its main drugs (Vimpat) and not told the market. See here and here. EBIT is likely to fall 30-40 percent eventually. The company might dain one day to fill shareholders in on the details. The numbers are really not pretty but without proper company disclosure it is impossible to make an accurate estimate. For almost two weeks I have expected the UCB to make a statement. But they have kept silent failing to disclose key information to the market.The patent's death certificate was only sent by the United States Patent and Trademark office last Monday and there are different time-zones and languages to deal with. So I drafted the blog-posts gently, expecting a confirming press release along with accurate statement of prognosis from the company.The patents death certificate is however almost certainly final. This is a clear statement of fact by the Patent Office against the patent. Appeals against patents are almost always on matters of law - and courts are reluctant to overturn fact-finders. All previous actions against this patent have been on law. A finding of fact against UCB is devastating. This is not ordinary course of business patent litigation. In the ordinary course of business UCB has wound up in patent disputes with other companies (eg Mylan, Argentum). And those disputes have been where the assumption is that UCB has a valid patent.This time it is in dispute with the US Government. And the US Government is stating there is no valid patent. Ask other European companies how disputes with the US Government pan out.Moreover the burden of proof has changed. UCB now has to get its patent approved under de-novo standards when the Patent Office has already rejected the patent. Of course none of this seems to warrant any statement from UCB.Lower standardsI am going to be blunt. Withholding a piece of information this significant from the market in the US would result in a fairly nasty SEC inquiry complete with subpoenas to determine who knew what and when. I have made relatively few investments in Belgium so I can't tell whether the Belgian regulatory standards are lower or the standards are just lower at UCB.But standards are very low here.In the US if a single insider has sold whilst in possession of this information (which was unreleased to the market) they could expect close investigation by Preet Bharara. I don't know what standards apply in Belgium.As stated in previous postsI found the IR officers we met of very high integrity. But this has to extend higher than this. I think it has to rise to the level of Jean-Christophe Tellier - the well regarded CEO.The Jean-Christophe Tellier was described in the press release announcing his appointment as playing "a key role in driving the growth of UCB’s three core medicines, Cimzia®, Vimpat® and Neupro®."Presumably he knows that his strategy surrounding those drugs is dead. Presumably he is part of withholding that information from the market.In the US his days as CEO would be numbered.I can only presume that standards are lower in Belgium. But if UCB claims to have high standards Mr Tellier should be fired.John

12 декабря 2016, 10:17

UCB's lack of candour

This is a follow up to last Friday's post about UCB - the large Belgian pharmaceuticals company. It probably helps if you read that post first.In Friday's post I outlined the state of play regarding UCB's important Vimpat patent. Disputes about that patent have been background for the stock for some time. When I went to visit UCB in Belgium (1 December 2015) the IR officers were straightforward about this. Third party patent challenges were the bear story on the stock. But UCB has since then touted victories in their patent disputes and regularly touted extensions of the Vimpat franchise.On 14 August 2016 UCB released a press release titled U.S. District Court confirms validity of patent for UCB's Vimpat®. That press release detailed a key victory against one of two third-party challengers of the patent. The stock went up sharply. UCB has made many press releases detailing just how important the Vimpat franchise is to them. When the CEO (Jean-Christophe Tellier) was appointed the press release stated: "Jean-Christophe Tellier joined the company in 2011 and was instrumental in establishing the company’s current strategy; he has played a key role in driving the growth of UCB’s three core medicines, Cimzia®, Vimpat® and Neupro®."UCB has been active in touting Vimpat both in the EU and the US as a monotherapy for epilepsy. (See here and here.)UCB has been extremely active extending labels for Vimpat in Japan. (See here for an example.)Indeed extensions of the Vimpat franchise have been important in UCB's growth strategy.So it was deeply surprising to us when UCB neglected to tell the market that US Patent Office had reviewed the patent (an ex-parte review) and had decided to withdraw the patent entirely. [You can find the letter that the Patent Office sent here.]This is an unusual move. Since the ex parte examination system was introduced (35 years ago) about 13,500 ex parte requests for examination has been made just over a thousand of them have had all claims rejected. You can find statistics here. Rejected here is a term of art. A claim is "objected" for all sorts of formal reasons like the claims not being properly grouped. A "rejection" is a determination that the claim is not patentable - and is appellable to the Patent Trial and Appeal Board (a court) and then to the court system. This is altogether a different type of threat to UCB. Past patent disputes have been with other companies wanting to release a generic - and thus far UCB has either had the case thrown out or got a significant delay. These are standard commercial disputes with commercial parties. And in every one of these disputes the court has worked on the assumption that UCB has a valid patent and the question is whether the other party is infringing on this patent. This dispute is with the US Government. The US Government has reviewed past decisions and decided that Vimpat is simply non-patentable. That is the US Government has determined that UCB does not own a valid patent. Sure UCB has two months to try and convince a (well informed) patent examiner otherwise - but their chances of this are low. The patent examiner will be experienced in this area and it is not as if the bureaucrat was uninformed that this was a controversial and important case.After the two months has elapsed UCB could appeal to the Patent Trial and Appeal Board. However the standard here is the de-novo patent standard. The situation is as if Vimpat had its original patent comprehensively rejected and it has to appeal to a court against the scientist/reviewers at the Patent Office. The courts are usually pretty deferential to the examiners at the Patent Office on the basis that they have the disinterested expertise to assess patents. In this case Johnny Railey was the examiner and he is amongst the most experienced biotech patent examiners in the US. You can find his linked in CV here. You can find a very extensive list of patents in which he was the examiner here. Appeals of this kind almost always fail. As Johnny Railey is amongst the most experienced patent examiners the chance of an appeal succeeding is even lower.For practical purposes the Vimpat patent is almost certainly dead - and UCB's much ballyhooed growth strategy will die with it.I am surprised at the lack of a management press release.Disputes with the US GovernmentUCB has press released interim victories in District Court against commercial claimants on the Vimpat patent.Their IR officers have been willing to give up-to-date reports of the (mostly) favourable commercial disputes they have.But there is not a word here that their (new) dispute is with the US Government and the default position from here (statistically likely to be upheld) is that they will lose their patent in its entirety.Not disclosing a business-critical dispute with the US Government is strange.Whatever: shareholders should ask themselves how other European companies have prevailed in dispute with the US Government.John

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09 декабря 2016, 15:40

UCB's Vimpat patent

UCB is a Belgium-based biopharmaceutical and specialty chemical company that specialises in two therapeutic areas: diseases of the central nervous system and immunology. The main central nervous system speciality is epilepsy and the main drug in this area is Vimpat. (UCB revenue mostly comes from four drugs of which Vimpat is one.)We went to visit UCB once, a cold and wet wintery day where we got modestly lost in Belgium.The investor relations people were straightforward. We were new to the story and our notes state clearly that generic challenges to the Vimpat patent were the main bear story for the stock. Our notes also talk about Keppra - another epilepsy drug. When it went off patent revenues dropped substantially. Keppra was an famous "patent cliff" drug.The risk to Vimpat has been reflected in the press too. Fierce Pharma - an industry rag - reports that August 15 this year was the best day for UCB in years as a Delaware District Court had rejected challenges to the Vimpat patent. Notwithstanding this, Fierce Pharma noted that the patent still faced challenges. To quote:UCB isn’t totally out of the woods, though. In late May, New York-based generics maker Argentum Pharmaceuticals won an inter partes review of Vimpat’s patent protection by the U.S. Patent & Trademark Office (PTO)’s Patent Trial & Appeal Board (PTAB). And that decision may not be handed down until next May. Still, court’s decision is a “long-awaited sentiment boost” for UCB, whose shares had fallen by about 17% so far this year, Citigroup analysts wrote in a Monday note seen by Bloomberg. Despite the lingering risk of patent invalidation, they wrote, “we expect market confidence to improve.”As noted Argentum Pharmaceuticals won an inter-parties review of Vimpat's patent. Argentum's press release however noted an even more aggressive request. To quote:Argentum also filed an ex parte reexamination request against this same patent that raises additional grounds of unpatentability than those in the IPR.  A decision by the PTO on Argentum's reexamination request is due no later than July 29, 2016.This is mentioned as afterthought in the press release because it is a really aggressive claim. Argentum asked the Patent Office itself to review the patent it previously granted and presumably throw out the original patent.Given the afterthought nature of that request I suspect even Argentum will be surprised that the ex-parte review rejected all thirteen claims of the Vimpat patent.In other words the Patent Office has thrown out the patent.This is all in a letter dated 5 December 2016 (that is just a few days ago). You can find that letter here. And according to that letter UCB has only two months to dispute the total rejection of the patent by the patent office.This rejection will of course be followed by Argentum and Mylan (and probably other companies) commencing distribution of a generic for Vimpat. Mylan were behind the above-mentioned court challenge.--It is - given the significance of this to the business - perhaps a little unusual that UCB has made no press release.--Is this the beginning of a new, more aggressive patent office?The political pressure in the US to do something to reduce drug prices is large. In the past election this was one area of near universal agreement.I am wondering whether we are going to see this sort of action by the Patent Office more widely.If the trend is more widespread it could be bad news for pharma investors generally.John

14 ноября 2016, 17:25

Amgen Presents Osteoporosis Data; Parsabiv Approved in EU

Amgen, Inc. (AMGN) and partner UCB S.A. (UCBJF) announced results from the pivotal phase III BRIDGE study which showed that its pipeline candidate, romosozumab, significantly increases bone mineral density in men with osteoporosis.

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30 октября 2016, 19:01

UCB taps innovation to help Chinese patients

BELGIAN drugmaker UCB’s efforts to improve quality of life for people with severe diseases have benefited millions of Chinese patients in the past two decades. The Brussels-based multinational bio­pharmaceutical

26 октября 2016, 16:48

Dr. Reddy's (RDY) Earnings & Revenues Decline Y/Y in Q2

Dr. Reddy's Laboratories Ltd. (RDY) reported second-quarter fiscal 2017 earnings per American Depositary Share (ADS) of 27 cents, down 57.1% year over year.

25 октября 2016, 23:29

Helen of Troy's Oxo Brand to Develop New Injection Device

Consumer products company Helen of Troy Limited (HELE) is all set to boost its presence in the health and wellness business.

13 октября 2016, 21:56

Commodities, International Finance, and Real Exchange Rates

Those are the topics covered tomorrow (Friday, 10/14) at the 5th annual West Coast Workshop in International Finance 2016, taking place at Santa Clara University. As usual, these look like a set of fascinating papers, and a must-see for those interested in international finance/open economy macro (A post discussing last year’s conference proceedings is here). […]

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28 сентября 2016, 15:51

Biotech Stock Roundup: Amgen's Kyprolis Disappoints, Array Up on Cancer Data

Although Amgen (AMGN) gained FDA approval for its biosimilar of Humira, Kyprolis data disappointed.

27 сентября 2016, 17:12

Amgen/UCB's BLA for Osteoporosis Drug Accepted in the U.S.

Amgen Inc. (AMGN), along with its partner UCB S.A. (UCBJF), a global biopharmaceutical company, announced that the FDA has accepted their Biologics License Application (BLA) for romosozumab for the treatment of osteoporosis.

19 сентября 2016, 17:38

Amgen (AMGN) Parsabiv Gets Positive CHMP Opinion in EU

Amgen, Inc.'s (AMGN) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion for its pipeline secondary hyperparathyroidism (SHPT) candidate Parsabiv (etelcalcetide).