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Sunday, January 6, 2019

Adamas Prelim Q4, 2018 GOCOVRI Sales Results, 2019 Key Priorities


— GOCOVRI preliminary net sales of approximately $13.3 million for the fourth quarter of 2018 and approximately $34 million for the year —
— Preliminary total prescriptions of approximately 5,700 for the fourth quarter of 2018 and  approximately 15,500 for the year —
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system (CNS) disorders, today outlined key business priorities for 2019 and provided preliminary 2018 sales results for GOCOVRI™ (amantadine) extended release capsules.  GOCOVRI is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy and only medication clinically proven to reduce both dyskinesia and OFF in that population.
“We are pleased to finish 2018 in a strong position, after the commercial launch of GOCOVRI,” said Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “GOCOVRI has had a positive and durable impact on Parkinson’s disease patients with dyskinesia, and we look forward in 2019 to continuing to promote and demonstrate the value of GOCOVRI to all stakeholders.  In addition, our development programs have advanced in 2018 with the strong enrollment of our INROADS Phase 3 trial for ADS-5102 in patients with multiple sclerosis walking impairment and the progress in our ADS-4101 program, which will continue in 2019.  Finally, we continue to be confident in breadth and strength of the intellectual property portfolio that we have established to protect our products, programs and other innovations.”
Preliminary Unaudited Fourth Quarter and Full-Year 2018 Sales for GOCOVRI
Based on preliminary unaudited financial information, the company expects net sales of GOCOVRI to be approximately $13.3 million for the fourth quarter ended December 31, 2018.  During the fourth quarter, Adamas fulfilled approximately 5,700 paid prescriptions of GOCOVRI.  Preliminary full-year unaudited net sales of GOCOVRI are expected to be approximately $34 million, with approximately 15,500 paid prescriptions filled.  Adamas ended the year with approximately $211 million of cash, cash equivalents, and available-for-sale securities.
Key Priorities for 2019
GOCOVRI commercialization:
  • Drive adoption and clinical conviction through commercial execution and focused education about the innovation and unique benefits of GOCOVRI
  • Continue to maintain excellent persistence and durable use through positive patient experience
  • Target an approximate doubling of total prescriptions for 2019 over 2018
  • Advance the medical literature regarding GOCOVRI in the Parkinson’s disease treatment journey and time dependent mechanisms of disease and action by continuing to publish data at major scientific and medical meetings, including American Academy of Neurology (AAN) and International Parkinson and Movement Disorder Society (MDS)
Development Pipeline:
  • Expect completion of enrollment for the Phase 3 INROADS study of ADS-5102 (amantadine) extended release capsules for multiple sclerosis walking impairment in the first half of 2019 and release top-line data in the second half of 2019
  • Continue to advance ADS-4101 towards registration studies
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Viking Therapeutics to Present at Biotech Showcase 2019


Viking Therapeutics, Inc. (“Viking”) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that its chief executive officer, Brian Lian, Ph.D., will deliver a corporate presentation at the 11th Annual Biotech Showcase™, being held January 7-9, 2019 at the Hilton San Francisco Union Square in San Francisco.
Details for this presentation are as follows:
  • Biotech Showcase 2019 – webcast availableTime/Date: 11:30 a.m. PT on Monday, January 7, 2019Location: Hilton San Francisco Union SquareRoom: Yosemite C
To access the live webcast of Viking’s presentation, please visit “Webcasts & Presentations” within the News & Events section of Viking’s Investors page at www.vikingtherapeutics.com. Additionally, a replay of the webcast will be available on the Viking website following the conference.

Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders.  The company’s research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients’ lives.  The company’s clinical programs include VK2809, a small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, including non-alcoholic steatohepatitis (NASH).  In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content. VK2809 was shown to be safe and well-tolerated in the study.  The company is also developing VK0214, a small molecule selective thyroid hormone receptor beta agonist for the treatment of X-linked adrenoleukodystrophy.  The company’s other programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator.  In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared to patients who received placebo.  Other programs also include VK0612, a first-in-class, orally available drug candidate in Phase 2 development for the treatment of type 2 diabetes as well as two earlier-stage programs targeting metabolic diseases and anemia.  Viking holds exclusive worldwide rights to a portfolio of five therapeutic programs, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.
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Aptose Biosciences to Present at Biotech Showcase(TM) 2019 Conference


Aptose Biosciences Inc. APTO, +6.25% (APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, today announced that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, and Gregory K. Chow, Senior Vice President and Chief Financial Officer, will participate at the upcoming Biotech Showcase(TM) 2019 Conference on Monday, January 7, 2019 at 11:00 a.m. PST in San Francisco, CA.
Conference Presentation Details:
Date: Monday, January 7, 2019
Time: 11:00 a.m. PST
Location: Track Yosemite – C (Ballroom Level)
Hilton San Francisco Union Square, 333 O’Farrell Street, San Francisco, CA 94102
Webcast: https://event.webcasts.com/starthere.jsp?ei=1226323&tp_key=d5803514a3
The audio webcast will be archived shortly after the live event and will be available through the Aptose website at https://ir.aptose.com/events-and-presentations/past-events.
The Company will also be hosting institutional investor and partnering meetings at the LifeSci Advisors Corporate Access Event taking place in San Francisco, on January 8 and 9, 2019.
To schedule a meeting with Aptose, investors can register on the online system managed by the Company’s US investor relations firm LifeSci Advisors, LLC, or make a request via e-mail at Access@LifeSciAdvisors.com.

Aptose Biosciences is a clinical-stage biotechnology company committed to developing personalized therapies addressing unmet medical needs in oncology, with an initial focus on hematology. The company’s small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities. APTO-253, the only known clinical stage agent that directly targets the MYC oncogene and inhibits its expression, is in a Phase 1b clinical trial for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) or high risk MDS. CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor being developed to treat AML and certain B cell malignancies. For further information, please visit www.aptose.com.
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bluebird bio to Present at J.P. Morgan


-bluebird bio, Inc. (Nasdaq: BLUE) today announced that members of the management team will present at the 37th Annual J.P. Morgan Healthcare Conference, Tuesday, January 8, at 2:30 p.m. PT at the Westin St. Francis Hotel, San Francisco, followed by a question and answer breakout session at 3:00 p.m.
To access the live webcast of bluebird bio’s presentation and breakout session, please visit the “Events & Presentations” page within the Investors & Media section of the bluebird bio website at http://investor.bluebirdbio.com. A replay of the webcast will be available on the bluebird bio website for 90 days following the conference.

With its lentiviral-based gene therapies, T cell immunotherapy expertise and gene editing capabilities, bluebird bio has built a pipeline with broad potential application in severe genetic diseases and cancer.
bluebird bio’s gene therapy clinical programs include investigational treatments for cerebral adrenoleukodystrophy, transfusion-dependent β-thalassemia and sickle cell disease.
bluebird bio’s oncology pipeline is built upon the company’s lentiviral gene delivery and T cell engineering, with a focus on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR T) and T cell receptor (TCR) therapies. The company’s lead oncology programs are anti-BCMA CAR T programs partnered with Celgene.
bluebird bio’s discovery research programs include utilizing megaTAL/homing endonuclease gene editing technologies with the potential for use across the company’s pipeline.
bluebird bio has operations in Cambridge, Massachusetts; Seattle, Washington; Durham, North Carolina and Zug, Switzerland. For more information, visit bluebirdbio.com.
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Saturday, January 5, 2019

South Korea’s Celltrion aims to set up China JV in first half of 2019: chairman


South Korean drugmaker Celltrion Inc aims to set up a joint venture in China within the first half of this year, and begin selling products in the country next year, its chairman said on Sunday.

“Since last year, we’ve been pushing on with a plan to set up a joint venture in China,” Chairman Seo Jung Jin told reporters. The firm has been in talks with several Chinese companies, he said, declining to elaborate.
Celltrion sells drugs known as biosimilars, mainly to Europe and the United States.
It is South Korea’s third-largest company by market value, after Samsung Electronics Co Ltd and chipmaker SK Hynix Inc, according to the Korea Stock Exchange.
On Friday, it said it would build a third domestic plant and is continuing to review potential manufacturing sites overseas.
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US loses, EU wins as Chinese biotech investment shifts focus


Chinese biotech investors are taking an interest in the European market as diplomatic relations with the US become strained. Richard Staines spoke to Nooman Haque, managing director of life sciences and healthcare at Silicon Valley Bank to find out more.
Sino-US relations are going through a fraught period, with the detention of Meng Wanzhou, chief financial officer of the Chinese tech firm Huawei in Canada just the latest in a series of diplomatic rows.
Meng has been charged with violating sanctions with Iran at the request of US authorities, and as the political relationship has soured, so has the trade relationship.
Although the US is now talking about cutting tariffs with China, the behaviour of president Trump is anything but predictable and the situation can change overnight.
The uncertainty is driving Chinese investors’ interest towards Europe as a place to invest in biotech, according to Nooman Haque, managing director of life sciences and healthcare at Silicon Valley Bank.
Figures released that emerged in the summer backed up Haque’s argument: they showed China is investing nine times more into Europe than it is into North America.
According to the report from multinational law firm Baker Mackenzie, newly-announced Chinese M&A activity into Europe in all sectors was $20 billion compared to $2.5 billion in North America in the first half of 2018.
The report showed foreign direct investment from China swung dramatically toward Europe – while US revenues fell 92% from $24 billion in the same period last year.
Biotech and health were among the main areas interesting Chinese investors in Europe, as well as the automotive industry.
Amid the growing trade tensions between the US and China, Chinese firms are also divesting in North America, according to the report, with $9.6 billion being divested in the first half of the year.
Haque told pharmaphorum in an interview: “The US’s loss is going to be Europe’s gain. It’s more because of the political climate.”
According to Haque there is a “growing recognition” amongst Chinese investors of the value in the European pharma and biotech market, in early and late stage development.
And the UK in particular is of interest because of the government’s decision to back the life sciences as part of its industrial strategy.
It’s not necessarily a conversation starter but could help to set the right tone during negotiations.
Haque said: “They certainly noticed that the strategy is being developed. I would not say that the specifics of the strategy are in the minds of the Chinese investors.”
However, getting a return in the short or medium term will be the main goal of Chinese investors, who will be looking for something that will pay off at the latest at some point in 2019.
Several European biotechs have already benefited from support from Chinese investors – such as UK-based Kymab.
Doing business with Chinese investors is also a different proposition from European and US counterparts, Haque said.
One of the main barriers to overcome is a lack of knowledge about markets and products, which will mean taking time to ensure deals reach a conclusion.
It’s important to think about the details of any deal, such as whether it will be a joint venture, and how it will be structured, according to Haque.
“Thinking creatively about how to get a deal done is going to be key,” said Haque.
Haque said: “Chinese venture capitalists won’t have the same knowledge of the market. It takes longer to acquire that knowledge.”
On the positive side, Chinese investors are starting to set up offices and ramp up their scouting operations in Europe to improve their knowledge, instead of basing deals on flying visits every few months or so.
He said: “We have seen a couple of firms putting a few people on the ground as scouting and contact points for the opportunities that are here. They are starting to show that initial commitment.”
The European biotech investment market lacks the scale of the US, but Haque predicts that Chinese investment will help it to grow in the near future.
Despite the big numbers in the Baker Mackenzie report, the Chinese investment will still not be enough to see the European market grow to the same size as the US market, said Haque.
But the Chinese investment will allow companies to grow and realise their ambitions – in particular allowing biotechs to grow, let their products gain traction and head through the development process, and go public at the right time.
A common issue in Europe is that biotechs often go public before they are ready to be publicly traded because the private venture capital is not available to drive the development process.
Chinese investment could go some way to solve this problem, according to Haque, and give European biotechs the breathing space to develop.
Haque said: “Overall it’s very positive. There has been a lot of capital in biotech, but what has been lacking is the capital to scale companies.”
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Ligand: Interesting Pharma Play On Sale


Ligand Pharmaceuticals is an interesting and diverse play on growth of the pharmaceutical industry.
I like the interesting business model, as Ligand appears to have a very rich pipeline.
A very strong momentum run has seen a big reversal, yet current valuations require further pipeline conversion to offer appeal.
Ligand Pharmaceuticals (LGND) is an interesting business with a distinctive business model, which actually looks quite compelling. Investors feel the same as shares have seen a huge run higher over the past few years, which has violently reversed course in recent months actually creating a more compelling situation currently.
Nonetheless, I am not actively buying a big stake just yet. For now I just hold a symbolic stake, as I require continued growth or a further pullback before buying a larger stake.

Ligand – The Alternative Business Model

Ligand itself explains quite well why it is pursuing an alternative strategy in the complicated pharmaceutical industry. It rightfully observes that most research programs fail and that not all programs are created equal in terms of risks and reward. Ligand aims to create the best of both worlds by connecting its patent, know how and data together with the research programs of partners, thereby creating the best of both worlds.
Specific tasks provided by Ligand include early research, drug discovery, tools, data and patents, new technologies and assets. The combination of current revenues, pipeline and strong technology drive the value created by Ligand and has been the major force behind the huge run higher in the shares.
Over time, the portfolio of underlying approved drugs has grown dramatically, with underlying product revenues increasing from less than $400 million in 2012 to more than $2.3 billion in 2018. On these sales, the company has on average obtained royalty rates between 3.5% and 5.5% on aggregate, with current rates trending towards the higher of the range.
The company currently has a program with 178 (potential) drugs with over a 100 partners of which half is still pre-clinical phase. 18 products are being marketed and about 35% is in either phase 1, 2 or 3. Note that the partners of the company include all the major players within the industry. The underlying technology which makes Ligand a desired collaboration partner for these companies include the OmniAb and Captisol technologies. …
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