Category Archives: Topics

Biocon Malaysian Facility Receives Additional 483 Observations From FDA

Biocon has received an additional twelve 483 observations from an FDA inspection of Biocon’s Malaysian facility. The 483 observations were a result of an FDA pre-approval inspection for the bs-glargine product; however, the company did not provide any specific details. No result was found during a search of FDA’s inspection citations. According to Biocon, the inspection is not anticipated to impact plans for US commercialization. Below, FENIX provides context and insight regarding these 483 observations.

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Janssen-Hanmi Ends Ph2 Dual Agonist; Sanofi Efpeg Deal Restructured

Recently, there have been two seemingly interrelated announcements from Hanmi regarding the termination of their GLP-1/GCG dual agonist partnership with Janssen and a restructuring of the deal with Sanofi for efpeglenatide. Below, FENIX provides a summary of these news items and potential read-through.

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Connected Care: Sanofi/Biocorp Exclusive Data Partnership

Today, Biocorp and Sanofi announced they have entered into exclusive negotiations for integrating Biocorp’s connected cap device into the Sanofi connected care platform. Below, FENIX provides read-through on what the Biocorp-Sanofi deal may signal.

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Beta Bionics Raises $63M in Series B2 Financing

Beta Bionics announced the closing of a $63M Series B2 financing round 6 months after an additional $63M Series B round. According to the press release, the funds will be used to complete final product development, Ph3 clinical trials, regulatory submissions, and the commercial launch of the iLet system. Below, FENIX provides additional thoughts on Beta Bionics and the iLet system.

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Thoughts on OneDrop/Apple BGM Distribution

One Drop recently announced that its BGM platform is now available in select US Apple stores. The One Drop BGM platform, which includes a mobile app, integrates with Apple HealthKit and is able to send data directly to an iPhone or Apple Watch. This is One Drop’s second large distribution agreement in 2019. In March, One Drop announced a partnership with Amazon to be part of Amazon’s Choice. Below, FENIX provides thoughts on why the distribution agreement makes sense for both One Drop and Apple.

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Farxiga DECLARE Positive CHMP Opinion

AstraZeneca announced it received a positive CHMP opinion for the DECLARE CVOT. AZ is anticipated to comment on the US and EU DECLARE regulatory activities during its upcoming Q2 ’19 earnings call on July 25. Below, FENIX provides brief thoughts on the impending EMA approval in the context of the ongoing FDA review.

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Livongo Files for IPO

Livongo has filed for its IPO under the proposed ticker “LVGO”; however, the number of shares and price has not yet been decided. Recall, on March 7, 2019, it was reported by WSJ that Livongo was preparing for a 2019 IPO with a valuation >$1B. Below, FENIX provides a brief overview of key information from the S-1 filing as well as insight into the Livongo IPO including thoughts on how Livongo is under increasing pressure to drive adoption.

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Xeris/Insulet Partnership Discontinued? Ph2 Xeris Glucagon Bariatric Surgery Trial

Xeris Pharmaceuticals announced the first patient has been dosed in the Ph2 trial evaluating its ready to use glucagon in patients who experience hypoglycemia after undergoing bariatric surgery (PBH). Xeris previously discussed intentions to initiate this Ph2 trial in a press release from December 2018. Curiously, neither of the press releases nor the CT.gov record makes any reference to delivery via the Insulet Omnipod which had been used in previous Xeris clinical trials with published clinical results. Below, FENIX provides insight into potential reasons why this trial is not using Omnipod.

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HF Trial Draft Guidance Issued by FDA; Public Hearing in July 2019

FDA announced it has issued draft guidance titled, “Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry” (download HF draft guidance here). Additionally, FDA will be hosting a public workshop on Friday, July 26, 2019, from 9am to 4pm ET at the White Oak Campus.

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High-dose Trulicity Topline Results; Jardiance Fast Track Designation for HF

Lilly announced positive topline results from its AWARD-11 study evaluating high-dose Trulicity (3.0 and 4.5mg). Separately, Boehringer Ingelheim and Lilly announced they have received Fast Track designation for the Jardiance heart failure indication based on the ongoing EMPEROR clinical trials. Of note, Lilly did not provide details on the A1C or weight reduction observed in AWARD-11. Below, FENIX provides insight and context on the Jardiance HF Fast Track designation as well as thoughts on AWARD-11 and the potential magnitude of effect with Trulicity 3.0 and 4.5mg doses.

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