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25 мая, 16:30

The Zacks Analyst Blog Highlights: Regeneron, Amgen and Celgene

The Zacks Analyst Blog Highlights: Regeneron, Amgen and Celgene

24 мая, 15:37

Biotech Stock Roundup: FDA Nod for Regeneron RA Drug, Amgen Hit by Study Data

Key highlights in the biotech sector include FDA approval for Regeneron's (REGN) Kevzara and data from Amgen and Celgene.

23 мая, 17:38

Adamas Epilepsy Drug Shows Positive Result in Phase Ia Study

Adamas Pharmaceuticals, Inc. (ADMS) announced positive data from thephase Ia study evaluating ADS-4101 (lacosamide) for the treatment of partial onset seizures in epilepsy.

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22 мая, 17:57

Safety risk for Amgen and UCB’s bone drug lifts rival Radius

Drugmaker’s shares plunge on fears osteoporosis medication will not win approval

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22 мая, 13:30

Основные фондовые индексы Европы торгуются смешанно

Рынки в Европе движутся разнонаправленно в понедельник, когда инвесторы оценили многомиллиардное слияние в химической промышленности и первый зарубежный визит президента Дональда Трампа. Общеевропейский индекс Stoxx 600 вырос на 0,12 процента, причем большинство секторов торгуются на положительной территории. Акции сектора базовых ресурсов показали рост в начале торгов, поднявшись более чем на 1 процент, так как фьючерсы на китайскую сталь приблизились к 6-процентному подъему в понедельник. Химические акции также немного выросли в начале торгов после новостей о слиянии между Huntsman Corporation и швейцарской Clariant. Эта сделка создает химический гигант стоимостью 14 млрд. долл. США. Акции Clariant были одними из самых эффективных в европейском индексе, поднявшись почти на 7 процентов. Страховщик Aegon оказался на вершине европейского индекса, поднявшись на 8 процентов, после того, как согласился продать некоторые американские компании, чтобы повысить свой баланс. Производственная компания Lafargeholcim назначила Яна Джениша своим новым главным исполнительным директором, что отправило акции компании на 4 процента выше в ранних сделках. Напротив, акции биофармацевтической фирмы UCB упали на 13 процентов. На это повлияли новости, что компания начинает вторую фазу клинического исследования в лечении ингаляционной биологической астмы. Президент Дональд Трамп должен посетить Иерусалим, где он, как ожидается, встретится с лидерами Израиля и Палестины. Позже на этой неделе Трамп встретится с членами НАТО в Брюсселе. Согласно Wall Street Journal, главы государств поддержат призыв Трампа увеличить расходы на оборону. Они намерены согласиться представить подробные планы о том, как они достигнут 2-процентного вклада в альянс от валового внутреннего продукта. Между тем, министры финансов еврозоны намерены встретиться в этот понедельник в Брюсселе - встреча, которая могла бы включать в себя некоторые разговоры об облегчении долгового бремени Греции. В минувшие выходные президент Франции Эммануэль Макрон подчеркнул свою приверженность продвижению более тесного сотрудничества в еврозоне на встрече с премьер-министром Италии Паоло Гентилони. На текущий момент FTSE 7495.29 24.58 0.33% DAX 12590.69 -48.00 -0.38% CAC 5322.53 -1.87 -0.04% Информационно-аналитический отдел TeleTradeИсточник: FxTeam

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22 мая, 10:14

UCB drops 13%, doesn't see 2017 approval for romosozumab osteoporosis treatment

This is a Real-time headline. These are breaking news, delivered the minute it happens, delivered ticker-tape style. Visit www.marketwatch.com or the quote page for more information about this breaking news.

11 апреля, 14:00

Why Is Agenus (AGEN) Down 16.8% Since the Last Earnings Report?

Agenus (AGEN) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.

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