Tag: Biotech

Quanterix: A Growth Story Just Began (1)

Quanterix (Nasdaq: QTRX) is building a razor-blade model just like Illumina. With its ultra sensitive detection, Quanterix is revolutionizing immunoassay especially in neurology, improving the industry’s capabilities to access/evaluate related molecular data, understand diseases better and designing drugs/trials around it.

In recent quarters, Quanterix saw a continued growth in its consumables, which is the bread-and-butter due to its recurring nature and higher margin (than selling instruments.

Of course, the instrument sales are important, as the cumulative count (or installed base) should drive more recurring revenues in consumables.

Currently, the consumables revenue / instrument is ~$70k per year.

A Meatless Future By CBInsights

  • traditional food companies consolidation/acquisition
  • startup companies making meat out of labs or plant-based products
    • In 2019, one of the world’s biggest alternative protein brands, Beyond Meat, the manufacturer of the plant-based Beyond Burger, went public at a valuation of almost $1.5B

Differences in numbers:

There are other related trends in meal replacement & dairy substitutes,
insect protein and seafoods

Why now:

  • Forces like urbanization, population growth, and a rising global middle class lead to greater meat consumption
  • Alternative protein sources can reduce the negative environmental impact associated with meat production
  • Consumers are seeking healthier food alternatives
  • Advances in ag tech and synthetic biology are enabling high-tech meatless products
  • Meatless consumption could alleviate ethical questions around current meat production practices
  • Alternative meats could reduce contamination, reducing global health problems

Full report here.

「What’s News in China」

BeiGene (NASDAQ: BGNE; HKEX: 06160), announced on Nov 14 that BRUKINSA™ (zanubrutinib) has received accelerated approval from the US FDA as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. This is the first time that the FDA approved a drug based on efficacy data that is predominantly from China. // reuters | BeiGene

Trip.com (NASDAQ: TCOM), formerly Ctrip.com (Nasdaq: CTRP) and TripAdvisor (Nasdaq: TRIP) announced a strategic partnership on Nov 6 to expand global cooperation, including a joint venture, global content agreements and a governance agreement. TripAdvisor will own 40% of the joint venture. Trip.com shall acquire up to 6.95 million TripAdvisor shares or TripAdvisor shares valued at USD317.6 million through open market transactions within one year following regulatory approvals. Trip.com will have a nomination right for one TripAdvisor board seat commencing upon the relevant regulatory bodies’ approvals of the transaction. // TripAdvisor

Luckin Coffee (NASDAQ: LK), a coffee chain founded in 2017 in China and operating only 9 stores that year, grew to 3,680 stores at the end of 2019 Q3, with quarterly revenue expanding more than 6-fold to RMB1,493.2 million from RMB227.1 million a year ago. Also mentioned in the earnings release, Luckin “strategically launched Luckin Tea as an independent brand and developed our new retail partnership model, .. engaged in ongoing discussions with potential strategic partners to set up joint ventures in markets outside of China.” // Luckin Coffee

Source: luckincoffee.com

「What’s News In China」

Shanghai Green Valley Pharmaceuticals (Green Valley, 绿谷制药) today announced on Nov 2 that China’s National Medical Products Administration (NMPA) has approved Oligomannate (GV-971) as new drug for the treatment of “mild to moderate Alzheimer’s disease (AD) and improving cognitive function.” It is the first novel drug approved for Alzheimer’s disease globally since 2003. The company is also planning a global phase 3 trial with sites in the U.S., Europe and other parts of Asia in early 2020 to support regulatory filings around the world. // prnewswire | fiercepharma

On Nov 5, Nio (NASDAQ: NIO), long being seen as the Tesla in China, announced its partnership with Intel’s Mobileye to build self-driving EVs. Under the planned collaboration, Mobileye will provide NIO with the design of the self-driving system building on the Mobileye AV Series, a L4 AV kit comprised of the Mobileye EyeQ® system-on-chip, hardware, driving policy, safety software and mapping solution. NIO will take on the automotive-grade engineering, integration and mass-production of Mobileye’s system for both consumer automotive markets and for Mobileye’s mobility-as-a-service (MaaS) applications. In addition to integrating the self-driving system into its vehicle lines, NIO will develop a specially configured variant of electric AVs that Mobileye will use as robotaxis, deployed for ride-hailing services in global markets. // TechCrunch| intel

36Kr (NASDAQ: KRKR), a Beijing-based news and data provider, known for tracking fundraising and tech related news in China, raised $20 million in its Friday debut on NASDAQ. The company is similar to TechCrunch or Crunchbase (its affiliated Crunchbase News). // Crunchbase News

Biogen’s Amyloid-beta Project Back In The Game, Planning To Submit BLA Early 2020

Earlier this year, Biogen discontinued the Phase III trial of aducanumab in March 2019 following a futility analysis. Biogen’s stock tanked more than 29 percent from $320.59/shr,  closing at $226.88/shr on March 21.

Expectations had been high for aducanumab as Goldman Sachs analysts had projected at one time that sales of the drug could reach $12 billion.

When Biogen said on October 22 that it is going to file its amyloid-beta MAb aducanumab for US approval based on discussions with the FDA, its share price reached $318.00 during the day and closed at $281.87/shr (up more than 26%).

What has changed

Biogen said that, far from throwing in the towel on aducanumab, it has been busy. A “type C” meeting with the US FDA took place in June to discuss a possible path forward; then, just yesterday, there was a second such meeting, at which a new analysis was discussed [EvaluatePharma]

While the issues are complex the group’s new analysis points to a single, simple fact, which has been aired before: if an amyloid-beta MAb can be dosed high enough, for long enough, without insurmountable toxicities, then it should show some effect in a sufficiently early Alzheimer’s population.

An amendment in March 2017 allowed ApoE4 carriers who had earlier been on either 6mg/kg or 10mg/kg to be titrated up to 10mg/kg. This saw more patients overall exposed to 10mg/kg, but crucially the December 2018 cutoff was too early for this effect to manifest itself.

Surprise! Biogen’s longer-term analysis of aducanumab
  Low dose High dose
Emerge Engage Emerge Engage
n=543 n=547 n=547 n=555
CDR-SB (original primary endpoint)
Reduction vs placebo -14% -12% -23% +2%
Nominal p value 0.117 0.236 0.010 0.825
Adas-Cog (one of 3 secondary endpoints)
Reduction vs placebo -14% -11% -27% -12%
Nominal p value 0.167 0.248 0.010 0.245
Source: Biogen presentation, EvaluatePharma

Read more on Biogen’s Aducanumab Update

Question Remained

From FierceBiotech:

Biogen saw a divergence between the data generated in the two studies at the time of the futility analysis but was unable to explain the finding. Now, Biogen thinks the greater exposure to the high dose in EMERGE is the primary driver of the divergence. Biogen pointed to the better results seen in a subset of ENGAGE patients it said were exposed to sufficient high-dose aducanumab to make its case.

As the trials were identically designed, Biogen needs a way to explain why patients in EMERGE had greater exposure to high-dose aducanumab. Biogen’s explanation centers on amendments it made to the protocol. The hypothesis is that the timing of enrollment in the trials meant the amendments had different effects in each study. Biogen knew that was possible but not that it could warp the data to the extent it now claims.

And the big question is what the FDA will make of Biogen’s case.

Umer Raffat, an analyst at the investment bank Evercore/ISI, first asked if the departure of Michael Ehlers, Biogen’s previous research and development chief, had anything to do with disagreements over the Alzheimer’s dataset. Vounatsos, the Biogen CEO, said that Ehlers’ departure was personal, implying that disagreement over data did not play a role. [STAT]

Additional, Raffat noted that the patients who did not complete seemed to show benefit as well. He called this “confusing” in a note to investors following the conversation.