Case 1:19-cv-00126-CFC-SRF Document 104 Filed 06/19/20 Page 104 of 249 PageID #:
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`info puragen
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`Mentor's Puragen and Puragen Plus Dermal Filler Products Approved in Canada Monday December 19, 8:30 am ET Non(cid:173)
`An imal-Based, Stabilized, Hyaluron ic Acid Dermal Filler Products Manufactured w it h Mentor's Patented DXL(TM)
`Technology
`
`SANTA BARBARA, Calif.--(BUSINESS WIRE)--Dec. 19, 2005--Mentor Corporation (NYSE:MNT - News), a leading su pplier of
`med ica l products in the United States and internationally, today annou nced that it has received approva l to begin
`marketing and distri buting its Puragen(TM) and Pu ragen Plus(TM) hyaluronic acid-based derm al fill er products in
`Canada. Both products are ind icated for t he correction of fa cial fo lds and w ri nkl es and for lip augmentat ion and w ill be
`distributed t hrough Mentor's Canad ian subsidiary.
`ADVERTISEMENT
`
`"Mentor's derma l fi ller products are important new options that help me optimize fa cial rejuvenation outcomes for my
`patients," commented Claudio De Lorenzi, M.D., Board Certified Plastic Surgeon and past-President of the Canadian
`Society for Aesthetic Plastic Surgery and current President of the Canadian Laser Aesthetic Surgery Society. "I am
`pleased to now have access to both of these products for my patients in Canada. It is important to have alternatives, and
`I predict that a product that contains anesthetic will be extremely popular among doctors and patients."
`
`The medical device license applications granted by Health Canada for Puragen and Puragen Plus were based on data
`from the Company's U.S. pivotal clinical trial for Puragen Plus. Both Puragen and Puragen Plus are uniquely stabilized
`through Mentor's patent-protected DXL(TM) technology, which introduces two discrete cross-linking reactions to
`provide improved product stability relative to all other commercially available hyaluronic acid based dermal fillers on the
`market in Europe, Canada and the United States. Puragen Plus is the only hyaluronic acid-based product on the market
`in Canada that is formulated with an anesthetic for improved patient comfort.
`
`"Puragen and Puragen Plus are Mentor's first products for the fast growing facial rejuvenation market, and we are
`pleased that they are now available in Canada," commented Joshua H. Levine, President and Chief Executive Officer of
`Mentor Corporation. "We are committed to developing and marketing leading products based on advancements in
`science and technology and expect to expand our portfolio with botulinum toxin and other products used in non-surgical
`cosmetic procedures in the future."
`
`Puragen was launched in Europe in May 2005. The CE Mark for Puragen Plus is pendi ng. In the United States, Mentor
`expects to complete the fi ling of its pre-market approval application for Puragen Plus in the fourth quarter of fi sca l year
`2006, w hich ends March 31, 2006.
`
`About Mentor Corporation
`
`1
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`AGNHA00435103
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`AGN-RVP-0458230
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`Exhibit 1104
`Prollenium v. Allergan
`IPR2019-01505 et al.
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`Case 1:19-cv-00126-CFC-SRF Document 104 Filed 06/19/20 Page 105 of 249 PageID #:
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`Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global healthcare market. The
`Company develops, manufactures and markets innovative, science-based products for the aesthetics, urologic
`specialties and clinical and consumer healthcare markets around the world. The Company's website is
`www.mentorcorp.com.
`
`Safe Harbor Statement
`
`All statements included or incorporated by reference in this release, other than statements or characterizations of
`historical fact, are forward-looking statements. These forward-looking statements are based on our current
`expectations, estimates and projections about our industry, management's beliefs and certain assumptions made by us.
`Forward-looking statements in this press release include but are not limited to those statements related to the "fast
`growing facial rejuvenation market", "our commitment to developing and marketing leading products based on
`advancements in science and technology", and "expect to expand our portfolio with botulin um toxin and other products
`used in non-surgical cosmetic procedures in the future." Forward-looking statements can also be identified by words
`such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should,"
`"would," "could," "provide," "potential," "continue," similar expressions, and variations or negatives of these words. In
`addition, any statements that refer to expectations, projections or other characterizations of future events or
`circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking
`statements speak only as of the date hereof and are based upon the information available to us at this time. Such
`information is subject to change, and we will not necessarily inform you of such changes. These statements are not
`guarantees offuture results and are subject to risks, uncertainties and assumptions that are difficult to predict.
`Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking
`statement as a result of various factors.
`
`The Securities and Exchange Commission filings of Mentor, including, without limitation, its Annual Reports on Form 10-
`K, subsequent quarterly reports on Form 10-Q, and recent Current Reports on Form 8-K, discuss important risk factors
`that could contribute to such differences or otherwise affect its business, results of operations and financial condition.
`Mentor undertakes no obligation to revise or update publicly any forward-looking statement for any reason.
`
`Contact:
`Mentor Corporation
`Peter R. Nicholson, 805-879-6082
`
`2
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`AGNHA00435104
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`AGN-RVP-0458231
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`Case 1:19-cv-00126-CFC-SRF Document 104 Filed 06/19/20 Page 107 of 249 PageID #:
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`TR: Keyword News: [hyaluronic]
`
`pour infos, nouveau HA filler avec lidocaine (REDEFYNE) -----Message d'origine-----
`
`Yahoo! Alerts Yahoo! News - My Alerts - Edit Alert
`Friday, February 17, 2006 11:05 AM PST
`
`Anika gets EU OK to sell wrinkle filler
`Mass High Tech Fri, 17 Feb 2006 7:43 AM PST
`The European Un ion has given Woburn-based An ika Therapeutics Inc. CE Ma rk approval to market its cosmetic tissue
`augmentation product, Redefyne, in the EU.
`
`Anika Therapeutics Receives CE Mark for its REDEFYNE(TM) Cosmetic Tissue Augmentation Product
`PR Newswire via Yahoo ! Finance Thu, 16 Feb 2006 1:45 PM PST
`An ika Therapeutics, Inc. today announced that it has received CE Mark approval to market its cosmetic tissue
`augmentation product, REDEFYNE, in the European Union. REDEFYNE is an injectable soft tissue filler for facia l wrinkles,
`scar remediation and lip augmentation.
`
`See more news stories that match my keyword
`
`You received this email because you subscribed to Yahoo! Alerts. Use this link to unsubscribe from this alert. To change
`your communications preferences for other Yahoo! business lines, please visit your Marketing Preferences. To learn
`more about Yahoo!'s use of personal information, including the use of web beacons in HTML-based email, please read
`our Privacy Policy. Yahoo! is located at 701 First Avenue, Sunnyva le, CA 94089.
`
`1
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`Case 1:19-cv-00126-CFC-SRF Document 104 Filed 06/19/20 Page 109 of 249 PageID #:
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`To:
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`Importance:
`2008
`MAIL_RECEIVED:
`BUSINESS WIRE 07.08 .08 Anika Therapeutics Announces.doc
`
`Normal
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`Pierre
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`About Elevess Anika's Elevess is t he first FDA a pp r oved i n jectable soft- t i ssue
`f il ler to combine hyaluronic acid (HA) and lidocaine , a loca l anes t he t ic that
`i mproves patient comfort, and provides phy.sicians with a ne w a l te r na tive f or t h e ir
`aesthe t ic p ract i ce .
`
`- A
`
`llergan Inc.
`
`2525 Dupont Drive
`
`Irvine, CA 92612
`
`@allerqan.com
`
`This communication may contain information that is confidential and/or privileged If you are not
`the intended recipient or believe that you have received this communication in error,
`please promptly delete this communication, including any attachments, and notify the sender.
`
`AGNHA00493310
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`AGN-RVP-0367989
`AGN-RVP-0367989
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`Case 1:19-cv-00126-CFC-SRF Document 104 Filed 06/19/20 Page 111 of 249 PageID #:
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`BUSINESS WIRE
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`Anika Therapeutics Announces Exclusive U.S. Distribution Agreement For Elevess Injectable
`Dermal Filler ; Anika's HA-Based Dermal Filler Incorporating Lidocaine To Be Distributed By Artes
`Medical
`July 8, 2008
`
`Anika Therapeutics, Inc., a leader in products for tissue protection, healing and repair based on
`hyaluronic acid (HA) technology, announced today that it has signed an exclusive agreement with Artes
`Medical, Inc. , a medical aesthetics company, to distribute and market ELEVESS™, Anika's cross-linked
`hyaluronic acid-based (HA) injectable dermal filler. ELEVESS is an injectable filler that reduces the
`appearance of facial wrinkles and folds such as nasolabial folds, and is the first HA-based dermal filler
`approved by the Food and Drug Administration ("FDA") to incorporate the anesthetic lidocaine to improve
`patient comfort. Artes Medical manufactures, markets and sells ArteFill(®), the first and only FDA(cid:173)
`approved , nonresorbable dermal filler for the correction of smile lines.
`
`"We are very pleased to reach this agreement with Artes Medical to distribute ELEVESS, our
`breakthrough dermal filler product," said Anika President and Chief Executive Officer Charles H.
`Sherwood, Ph .D. "After undertaking an extensive search with a number of potential commercialization
`partners, we believe that Artes Medical possesses the capabilities that can help ELEVESS achieve its
`full potential in the marketplace. Artes' highly experienced sales force has well established relationships
`with the leading aesthetic physicians in markets throughout the United States. In addition, their
`complementary product, deep understanding of the injectable dermal filler marketplace and compatible
`culture make this a highly synergistic agreement for both companies." Under the terms of the agreement,
`Artes Medical will receive exclusive distribution and marketing rights for ELEVESS in the United States.
`
`"Going forward, we are actively seeking partners with characteristics and capabilities similar to Artes
`Medical to help us distribute ELEVESS in Europe, Canada, and the rest of the world," said Sherwood.
`"Our hopes are high for this product and we are eager for an increasing number of doctors and patients to
`experience its benefits."
`
`About ELEVESS:
`
`Anika's ELEVESS is the first FDA approved injectable dermal filler to combine hyaluronic acid (HA) and
`lidocaine, a local anesthetic that improves patient comfort, and provides physicians with a new alternative
`for their aesthetic practice. Hyaluronic acid is a naturally occurring polymer found throughout the body
`and is present in the skin, where it supports skin structure and elasticity. Designed for longer durability
`based on its proprietary cross-linking technology and its high concentration of Anika's chemically modified
`hyaluronic acid, ELEVESS has been approved for sale in the United States, the European Union and
`Canada.
`
`About Anika Therapeutics, Inc.
`
`Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops, manufactures and commercializes
`therapeutic products for tissue protection, healing and repair. These products are based on hyaluronic
`acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Anika's products
`include ORTHOVISC(®), a treatment for osteoarthritis of the knee available internationally and marketed
`in the U.S. by DePuy Mitek; HYVISC®, a treatment for equine osteoarthritis marketed in the U.S. by
`Boehringer lngelheim Vetmedica, Inc.; the ELEVESS™ family of aesthetic dermatology products for
`facial wrinkles, scar remediation and lip augmentation; AMVISC®, AMVISC® Plus, STAARVISC™-11 and
`Shel Igel™ injectable viscoelastic HA products for ophthalmic surgery; INCERT(®), an HA-based anti(cid:173)
`adhesive for surgical applications; ORTHOVISC(®) Mini a treatment for osteoarthritis targeting small
`joints and available in Europe; MONOVISC™ a single-injection osteoarthritis product based on its
`proprietary cross-linking technology and available in Europe; and next generation products for joint health
`and aesthetic dermatology based on the Company's proprietary, chemically modified HA.
`
`AGNHA00493311
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`AGN-RVP-0367990
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`Case 1:19-cv-00126-CFC-SRF Document 104 Filed 06/19/20 Page 112 of 249 PageID #:
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`Forward-Looking StatementsThe statements made in this press release which are not statements of
`historical fact are forward-looking statements within the meaning of Section 27 A of the Securities Act of
`1933 and Section 21 E of the Securities Exchange Act of 1934, including, without limitation, statements
`that may be identified by words such as "expectations," "remains," "focus," "expected," "prospective,"
`"expanding," "building," "continue," "progress," "plan(s)," "efforts," "hope," "believe," "objectives,"
`"opportunities," "will ," "seek," "expect" and other expressions which are predictions of or indicate future
`events and trends and which do not constitute historical matters identify forward-looking statements.
`Specifically, these statements include a risk that (i) a material amount of sales of ELEVESS will not occur,
`(ii) the Company's efforts to enter into long-term marketing and distribution arrangements with new
`international distributors for ELEVESS, will not be successful, (iii)) competitive products will adversely
`impact the Company's product sales, or (iv) the markets for which the Company has targeted its products
`will fail to be achieved, any of which may have a material adverse effect on the Company's business and
`operations. Certain other factors that might cause the Company's actual results to differ materially from
`those in the forward-looking statements include those set forth under the headings "Business," "Risk
`Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations"
`in each of the Company's Annual Report on Form 10-K for the year ended December 31, 2007 and on
`Form 10-Q for the period ended March 31, 2008, as well as those described in the Company's other
`press releases and SEC filings .
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`AGNHA00493312
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`Case 1:19-cv-00126-CFC-SRF Document 104 Filed 06/19/20 Page 116 of 249 PageID #:
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`From:
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`Attachments:
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`Merci -
`
`de l'infos.
`
`Lebreton_Pierre
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`, 2008
`
`RE:
`image0lO.gif; image0ll.gif; image012.gif; image013.gif; image014.gif; image015.gif;
`image016.gif; image017.gif; image018.gif
`
`Est-ce le Hylaform (version HA d'origine non animal) avec lidocaine?
`
`11 lancerait le produit avant d'avoir la gamme complete avec lido disponible ?
`
`Pierre
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`De:
`Envoye:
`A : Lebreton Pierre;
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`, 2008
`
`Report
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`2008
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`Envoye:
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`- D
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`e:
`Objet:
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`AGNHA00482689
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`Case 1:19-cv-00126-CFC-SRF Document 104 Filed 06/19/20 Page 117 of 249 PageID #:
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`DERMAL FILLERS
`
`Business Wire
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`Mentor Corporation Announces FDA Approval of Prevelle Silk: First Dermal Filler ...
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`2
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`AGNHA00482690
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`Case 1:19-cv-00126-CFC-SRF Document 104 Filed 06/19/20 Page 118 of 249 PageID #:
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`Mentor Corporation announced that the FDA has approved Prevelle Silk. This is the first of a new line of lidocaine
`containing hyaluronic acid (HA) dermal fillers that Mentor anticipates marketing and distributing globally.
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`-
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`3
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`AGNHA00482691
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`Case 1:19-cv-00126-CFC-SRF Document 104 Filed 06/19/20 Page 119 of 249 PageID #:
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`Case 1:19-cv-00126-CFC-SRF Document 104 Filed 06/19/20 Page 121 of 249 PageID #:
`4319
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`From:
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`To:
`Subject:
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`Lebreton_Pierre
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`restylane with lidocaine
`
`-In case you didn't get the information
`
`QMED finally succeeded in formulating restylane with lidocaine. See below
`
`Pierre
`
`"ClinicalTrials.gov processed this record on November 28, 2008
`
`Safety Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
`
`This study is currently recruiting participants.
`Verified by Medicis Global Services Corporation, November 2008
`
`Medicis Global Services Corporation
`Q-Med Scandinavia, Inc.
`
`jEstimated Enrollment:
`!Study Start Date:
`I
`!Estimated Study Completion Date:
`i
`!Estimated Primary Completion
`!Date:
`!
`
`I
`
`60
`November
`2008
`January
`2009
`January
`2009 (Final
`data
`collection
`date for
`pnmary
`outcome
`measure)
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`1
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`AGNHA00441482
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`AGN-RVP-0464609
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