AI
Saturday, March 04, 2017 9:38:49 PM
Halozyme, “working to scale-up/validate/qualify” Avid II(Myford), as a manufacturer of bulk rHuPH20 under the Roche Collaboration, per their 12-31-16 10-K issued 2-28-17. (Thx for the find, BioBS2012 #288235).
HALO’s 12-31-16 10-K, iss. 2-28-17 (pg.12):
“In addition, we are working to scale-up, validate, and qualify a new facility operated by Avid [Avid II, “MYFORD”] as a manufacturer of bulk rHuPH20 for use in the products & product candidates under the Roche Collaboration.”
Pg.9: ROCHE COLLABORATION:
“In Dec. 2006, we and Roche entered into a collaboration & license agreement under which Roche obtained a worldwide, license to develop & commercialize product combinations of rHuPH20 and up to 13 Roche target compounds (the Roche Collaboration). Roche initially had the exclusive right to apply rHuPH20 to 3 pre-defined Roche biologic targets with the option to develop & commercialize rHuPH20 with 10 addl. targets. Roche had the right to exercise this option to identify addl. targets for 10 years. As of the 10 year anniversary of the Roche Collaboration in Dec. 2016, Roche had elected a total of 8 targets, 2 of which are exclusive.”
12-31-16 10-K: https://www.sec.gov/Archives/edgar/data/1159036/000115903617000014/halo-12312016x10k.htm
HALO: http://www.halozyme.com
...About rHuPH20: http://www.halozyme.com/technology-and-products/technology/technology
- - - - - - - - - - - -
12-12-16/CC/S.King: “Our 2 facilities have the potential to generate in excess of $80mm in revenue, leaving addl. capacity for revenue growth beyond the current FY and into next year. Even with this available capacity, we are moving forward with our plans to construct a 3rd Mfg. Facility in order to meet the anticipated commercial needs of our clients, while continuing to grow the business by bringing in new projects.” Current revenue backlog: $73mm, under signed contracts. http://tinyurl.com/hhn4gga
3-9-16/Qtly-PR: “Avid’s new state-of-the-art commercial bio-mfg. suite has been formally commissioned. The new facility will double the company’s prior mfg. capacity, supporting up to an addl. $40mm in revenue each year.” http://tinyurl.com/gom7md5
3-7-16/Avid II: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) – S.King: “We have already had a tremendous response to the new facility and look forward to continuing to grow our bio-mfg. business which is an integral part of our overall business strategy." http://tinyurl.com/za2j9mt
12-11-15/BioPharma: Avid Expansion into MYFORD Facility (Avid II) now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
12-10-15/CC – Robert Garnick: “With the Myford site (Avid II) now in the initial phase of GMP manufacturing, we have seen a significant increase in demand for production capacity. Although, we have just opened the doors at Myford, we are already contemplating our options to increase further mfg. Capacity. Although no decisions have been made, we are pleased to have what appears to be a growing opportunity in this important area of our business.” http://tinyurl.com/jkp885g
= = = = = = = = = = =
AVID BIOSERVICES, Inc. (Peregrine's Mfg. Subsidiary): http://www.avidbio.com
12-12-16: PPHM's Revs & Burns By Qtr Table, FY'07/Q1 thru FY'17/Q2 (q/e 10-31-16): http://tinyurl.com/hhn4gga (since 5-2006: Avid=$202.5mm, Total=$229.1mm, incl.Govt)
......Avid FY17 (fye 4-30-17) revs guidance: $50-55mm; committed 12-12-16 backlog: $73mm. Avid III being designed/already secured 25,000sf loc/expect compl=Late/2017. “Expect future sustainable profitability for the co. in 18mos.”
6-2-16: Corp.Update – Avid Expansion & Drug Development - http://tinyurl.com/zvmhqmr
5-23-16: Pete Gagnon (100pubs/presentations, 12+patents, 30 pending patents) Appointed VP/Process-Services of Avid http://tinyurl.com/hg6abdq – See Oct'15:
3-7-16/Avid II: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
12-10-15/Avid II: Avid Expansion into MYFORD Facility now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
6-17-15: Avid’s John Haney (ex-Genentech/Pfizer) speaking at BIO-INTL’5/Philly http://tinyurl.com/pnlquu3 & http://tinyurl.com/nl4vbgk
...”Designing & Implementing Avid’s New State-of-the-Art Single-Use Facility for Late Ph.3 & Commercial Prod.” - SK: "We've seen tremendous interest for production in the new facility, both from new & existing clients"
12-10-14: Avid to Double Mfg. Capacity (“expanding client roster; potential commercial launch of bavituximab”) http://tinyurl.com/mmc3qgy & http://tinyurl.com/kmdgq8t
. . .
4-5-10: Avid & Halozyme Expand Commercial Supply Relationship: http://tinyurl.com/yfdgsom
…"the companies extended their existing commercial supply agreement (CSA) for rHuPH20 and signed a new CSA for addl. partnered product candidates such as subcutaneous HERCEPTIN & GAMMAGARD with rHuPH20."
11-10-14: Avid & Cook remain Halozyme's 2 CMO's (also 12-21-12 HALO/Pfizer rHuPH20 deal): http://tinyurl.com/qbmokuy
HALO’s 12-31-16 10-K, iss. 2-28-17 (pg.12):
“In addition, we are working to scale-up, validate, and qualify a new facility operated by Avid [Avid II, “MYFORD”] as a manufacturer of bulk rHuPH20 for use in the products & product candidates under the Roche Collaboration.”
Pg.9: ROCHE COLLABORATION:
“In Dec. 2006, we and Roche entered into a collaboration & license agreement under which Roche obtained a worldwide, license to develop & commercialize product combinations of rHuPH20 and up to 13 Roche target compounds (the Roche Collaboration). Roche initially had the exclusive right to apply rHuPH20 to 3 pre-defined Roche biologic targets with the option to develop & commercialize rHuPH20 with 10 addl. targets. Roche had the right to exercise this option to identify addl. targets for 10 years. As of the 10 year anniversary of the Roche Collaboration in Dec. 2016, Roche had elected a total of 8 targets, 2 of which are exclusive.”
12-31-16 10-K: https://www.sec.gov/Archives/edgar/data/1159036/000115903617000014/halo-12312016x10k.htm
HALO: http://www.halozyme.com
...About rHuPH20: http://www.halozyme.com/technology-and-products/technology/technology
- - - - - - - - - - - -
12-12-16/CC/S.King: “Our 2 facilities have the potential to generate in excess of $80mm in revenue, leaving addl. capacity for revenue growth beyond the current FY and into next year. Even with this available capacity, we are moving forward with our plans to construct a 3rd Mfg. Facility in order to meet the anticipated commercial needs of our clients, while continuing to grow the business by bringing in new projects.” Current revenue backlog: $73mm, under signed contracts. http://tinyurl.com/hhn4gga
3-9-16/Qtly-PR: “Avid’s new state-of-the-art commercial bio-mfg. suite has been formally commissioned. The new facility will double the company’s prior mfg. capacity, supporting up to an addl. $40mm in revenue each year.” http://tinyurl.com/gom7md5
3-7-16/Avid II: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) – S.King: “We have already had a tremendous response to the new facility and look forward to continuing to grow our bio-mfg. business which is an integral part of our overall business strategy." http://tinyurl.com/za2j9mt
12-11-15/BioPharma: Avid Expansion into MYFORD Facility (Avid II) now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
12-10-15/CC – Robert Garnick: “With the Myford site (Avid II) now in the initial phase of GMP manufacturing, we have seen a significant increase in demand for production capacity. Although, we have just opened the doors at Myford, we are already contemplating our options to increase further mfg. Capacity. Although no decisions have been made, we are pleased to have what appears to be a growing opportunity in this important area of our business.” http://tinyurl.com/jkp885g
= = = = = = = = = = =
AVID BIOSERVICES, Inc. (Peregrine's Mfg. Subsidiary): http://www.avidbio.com
12-12-16: PPHM's Revs & Burns By Qtr Table, FY'07/Q1 thru FY'17/Q2 (q/e 10-31-16): http://tinyurl.com/hhn4gga (since 5-2006: Avid=$202.5mm, Total=$229.1mm, incl.Govt)
......Avid FY17 (fye 4-30-17) revs guidance: $50-55mm; committed 12-12-16 backlog: $73mm. Avid III being designed/already secured 25,000sf loc/expect compl=Late/2017. “Expect future sustainable profitability for the co. in 18mos.”
6-2-16: Corp.Update – Avid Expansion & Drug Development - http://tinyurl.com/zvmhqmr
5-23-16: Pete Gagnon (100pubs/presentations, 12+patents, 30 pending patents) Appointed VP/Process-Services of Avid http://tinyurl.com/hg6abdq – See Oct'15:
3-7-16/Avid II: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
12-10-15/Avid II: Avid Expansion into MYFORD Facility now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
6-17-15: Avid’s John Haney (ex-Genentech/Pfizer) speaking at BIO-INTL’5/Philly http://tinyurl.com/pnlquu3 & http://tinyurl.com/nl4vbgk
...”Designing & Implementing Avid’s New State-of-the-Art Single-Use Facility for Late Ph.3 & Commercial Prod.” - SK: "We've seen tremendous interest for production in the new facility, both from new & existing clients"
12-10-14: Avid to Double Mfg. Capacity (“expanding client roster; potential commercial launch of bavituximab”) http://tinyurl.com/mmc3qgy & http://tinyurl.com/kmdgq8t
. . .
4-5-10: Avid & Halozyme Expand Commercial Supply Relationship: http://tinyurl.com/yfdgsom
…"the companies extended their existing commercial supply agreement (CSA) for rHuPH20 and signed a new CSA for addl. partnered product candidates such as subcutaneous HERCEPTIN & GAMMAGARD with rHuPH20."
11-10-14: Avid & Cook remain Halozyme's 2 CMO's (also 12-21-12 HALO/Pfizer rHuPH20 deal): http://tinyurl.com/qbmokuy
