Dermira, Inc. (NASDAQ:DERM) Files An 8-K Entry into a Material Definitive Agreement

Dermira, Inc. (NASDAQ:DERM) Files An 8-K Entry into a Material Definitive Agreement
Item 7.01 Entry into a Material Definitive Agreement.

Roche’s rights under this Agreement in the Retained Field will be relinquished to Dermira (the “Roche Reversion”): (a) at Roche’s election at any time following 30 days’ prior written notice to Dermira; or (b)automatically if at any time in a period of eighteen (18)consecutive months Roche is not conducting an active clinical study of lebrikizumab or recurring, bona fide activities aimed at receiving regulatory approval for the compound in the Retained Field, provided that such automatic reversion may not occur within three (3)years of the Effective Date or following regulatory approval for the compound in the Retained Field. Upon the occurrence of the Roche Reversion, all of Roche’s rights and all of Dermira’s obligations each with respect to the Retained Field will automatically expire, Dermira’s payment obligations that had been limited to indications outside the Retained Field will apply to all indications, and where the “first commercial sale” had applied to the first commercial sale other than for the Retained Field, the “first commercial sale” will apply to the first commercial sale in any indication.
Subject to certain conditions and limitations: (a)Dermira will have the right to sublicense the rights granted to it under the Agreement; (b)either party may terminate the Agreement in the event of an uncured breach of material obligations by, or certain insolvency events of, the other party or if expiration or termination of the waiting period under HSR has not occurred within six (6)months of the Execution Date; and (c)Dermira may terminate the Agreement at any time, on a country-by-country basis, upon six (6)months’ prior written notice before the first commercial sale of lebrikizumab (other than for the Retained Field) or upon nine (9)months prior written notice after the first commercial sale of the product (other than for the Retained Field).
Neither party may assign the Agreement or any part thereof prior to the occurrence of both (a)the Roche Reversion and (b)the first commercial sale of lebrikizumab (other than for the Retained Field), without the prior written approval of the other party, which shall not to be unreasonably withheld, conditioned or delayed. Following the occurrence of both the Roche Reversion and the first commercial sale of lebrikizumab (other than for the Retained Field), Dermira may assign the Agreement without Roche’s prior consent in the context of a merger, acquisition, sale or other transaction involving all or substantially all of Dermira’s assets. A party consummating a change of control transaction will provide written notice to the other party within agreed time periods prior to or following completion of the change of control transaction.
Roche shall indemnify Dermira for losses arising out of (a)Roche’s breach of any obligation, representation, warranty, covenant or agreement made by it under the Agreement, (b)development, manufacture or promotion of lebrikizumab in or for the Retained Field, including the sale of lebrikizumab by Dermira for use in the Retained Field, (c)Roche’s exercise of certain retained rights, development by Roche in the Retained Field, and promotion by Roche in the Retained Field, or (d)the manufacture of lebrikizumab by or on behalf of Roche.
Dermira shall indemnify Roche for losses arising out of (a)Dermira’s breach of any obligation, representation, warranty, covenant or agreement made by it under the Agreement, or (b)Dermira’s of development, manufacture, use, handling, storage, sale or other disposition of lebrikizumab (including product liability claims and infringement of third party patents).
The Agreement contains customary representations and warranties made by both parties.
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The foregoing summary of the Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the Agreement, which will be filed as an exhibit to Dermira’s Quarterly Report on Form 10-Q for the quarter ending September30, 2017.

Item 7.01 Regulation FD Disclosure.

Dermira anticipates the following corporate milestones in the second half of 2017:

Submission of a New Drug Application (“NDA”) to theU.S. Food and Drug Administration(“FDA”)for glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis.
Launch of Dermira’s hyperhidrosis disease awareness campaign.

Dermira anticipates the following corporate milestones in the first quarter of 2018:

Announcement of topline results from CLAREOS-1 and CLAREOS-2, the Phase 3 clinical trials investigating the safety and efficacy of olumacostat glasaretil in patients with acne vulgaris.
Initiation of a Phase 2b dose-ranging study assessing lebrikizumab in adult patients with moderate-to-severe atopic dermatitis, subject to the expiration or termination of waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, as amended, which Dermira anticipates will occur in the third quarter of 2017, and successful program transfer from Roche.

Dermira anticipates the following corporate milestones in the second half of 2018:

Commercial launch of Cimzia® (certolizumab pegol) for the treatment of moderate-to-severe chronic plaque psoriasis, subject to approval by the FDA of the supplemental Biologics License Application submitted by UCB Pharma S.A. to theFDA in July 2017.
Commercial launch of glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis, subject to approval by the FDA of the NDA which Dermira anticipates submitting to theFDA in the second half of 2017.

The foregoing disclosures constitute forward-looking statements within the meaning of Section21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.You should refer to the section entitled “Risk Factors” set forth in Dermira’s annual and quarterly reports and other filingsDermiramakes with theSECfrom time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermira’s forward-looking statements. The forward-looking statements speak only as of the date of this Current Report on Form 8-K.Dermiraundertakes no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

The information in this Item 7.01 is furnished to Item 7.01 of Form 8-K, and is not deemed to be “filed” for purposes of Section18 of the Exchange Act or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibits is not incorporated by reference in any filing of Dermira under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.

Item 7.01 Other Events.

On August 8, 2017, Dermira issued a press release announcing its entry into the Agreement. The press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 7.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Description of Exhibit

99.1 Press release dated August8, 2017.


Dermira, Inc. Exhibit
EX-99.1 2 d439272dex991.htm EXHIBIT 99.1 Exhibit 99.1 Exhibit 99.1   Dermira Enters into Agreement to License Exclusive,…
To view the full exhibit click here

About Dermira, Inc. (NASDAQ:DERM)

Dermira, Inc. is a biopharmaceutical company. The Company is focused on identifying, developing and commercializing differentiated therapies for dermatologic diseases. The Company’s portfolio includes three late-stage product candidates that target unmet needs and market opportunities, such as Cimzia (certolizumab pegol), DRM04 and DRM01. Cimzia is an injectable biologic tumor necrosis factor-alpha inhibitor, or TNF inhibitor, that is approved and marketed for the treatment of numerous inflammatory diseases spanning multiple medical specialties, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’s disease. DRM04 is a topical, small-molecule anticholinergic product for the treatment of hyperhidrosis. DRM01 is a topical, small-molecule sebum inhibitor for the treatment of acne.

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